(41 days)
The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is processed by the B1 device and then transmitted via a standard wireless link to a monitoring device, such as a P or hand-held device for display, review, printing, saving and post event processing by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.). Measurements taken by the BT devices are only significant if considered in connection with other clinical findings. No therapy or drugs can be administered based solely on ECG data derived from the BT devices. The BT devices are not intended for monitoring critical patients and are not intended for intracardial use.
BT3/6. BT12 is a compact ECG device which is worn on the body and is capable of wireless data transmission. With the BT3/6 type, 2 ECG leads (II - III according to Einthoven) can be measured via a 4-pin cable. The receiving unit can calculate four additional leads (lead I according to Einthoven, aVL, aVR, aVF according to Goldberger).Type BT12 has a 10-pin cable, which, in addition to the leads of the BT3/6 variant, can also measure the 6 leads according to Wilson. With this cable, one can select among 3-, 6- or 12-channel ECG measurements. The cables of the BT are pluggable and therefore can be easily changed. The electrode clips on the patient cables are suitable for connection to button and tab electrodes. It has an integrated electrode contact detector and a heart rate meter, the results of which are displayed on an integrated LCD display. Thanks to the integrated radio data transmission technology, BT3/6, BT12 is able to transmit ECG data online over a range of up to 10 m to a monitor or recording unit for further evaluation. BT3/6, BT12 can be used in all medical applications where the long, stiff trunk cables are a problem due to their weight, their motion artifacts or their electromagnetic susceptibility or because they limit the patient in his freedom of motion. Especially significant are the applications in which it is necessary for the patient to move around freely, for example when the patient is undergoing a stress electrocardiogram. BT3/6, BT12 is compact and simple to operate. A clip allows the device to the patient's clothing. BT3/6, BT12 is powered by two standard AA cells. Patient contacting components are the electrodes. BT3/6, BT12 is intended for use with approved. biocompatible electrodes only.
Here's an analysis of the provided text to extract the requested information regarding the acceptance criteria and study for the BT3/6, BT12 device.
Important Note: The provided document is a 510(k) Premarket Notification. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a full clinical comparative effectiveness study in the same way a PMA submission might. Therefore, some of the requested information (like effect size for MRMC studies or ground truth for training sets) may not be explicitly present because it's not a required component of a 510(k) for this type of device.
Acceptance Criteria and Device Performance
The device demonstrates compliance with recognized standards and shows performance characteristics that are comparable to or better than a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't define explicit "acceptance criteria" in a pass/fail sense for clinical performance. Instead, it compares the BT3/6, BT12 device's technical specifications and intended use against a legally marketed predicate device (Card Guard CG-7000DX-BT). The "acceptance" is based on demonstrating substantial equivalence, meaning the new device is as safe and effective as the predicate.
Here's a table summarizing the comparison for key parameters:
| Parameter | Acceptance Criteria (Predicate Device CG-7000DX-BT) | Reported Device Performance (BT3/6, BT12) |
|---|---|---|
| Intended Use | Similar - 12-lead ambulatory ECG for cardiac monitoring and diagnosis by medical professionals. | Similar, with added intent for 3/6-lead options and infants < 10 kg. Both collect, process, and transmit ECG data; no interpretation by device. |
| ECG interpretation software | No interpretation | No interpretation |
| Input dynamic range | +/- 5mV | +/- 5 mV |
| Frequency response bandwidth | Not explicitly stated for predicate in comparison table, but predicate claims conformance to EC11 and EC38. | 0.05-150Hz / according to EC11 and IEC 60601-2-51 |
| Resolution | 10 bit | 24 bit A/D converter (15 bit transmitted); 2.58 µV/bit. (Better than predicate) |
| Leads | 12 | 3/6 or 12 |
| CMRR (Common Mode Rejection Ratio) | 60 dB | >94 dB (Better than predicate) |
| Pacemaker detection | Yes | Yes |
| Input impedance | > 10 MΩ | 20 MΩ (Better than predicate) |
| DC offset correction | ± 75 mV | ± 190 mV (Better than predicate in stated performance claim) |
| ECG storage capacity | 4-20s length, 40-10 recordings (event recorder) | 5 min/12 channel when transmission is interrupted (stores during interruption, not for general event recording) |
| Temperature range (Operation) | 0...40°C | 0...50°C |
| Temperature range (Storage) | -20...65°C | -20...70°C |
| Display | LCD (graphic, low resolution) | LCD (displays on receiving unit only) |
| A to D sampling rate | 500 samples/sec | 500 samples/sec |
| Data transmission | Wireless | Wireless |
| Degree of protection against penetration of water | IPX0 | IPX3 (Better than predicate) |
| Defibrillation protection | Not defibrillation-proof (optional cable available) | Device not defibrillation-proof, but cable is. |
| Compliance to standards | Predicate claims conformance to ANSI/AAMI EC11:1991 and ANSI/AAMI EC38:1998 | Conforms to hardware requirements of EC11 and EC38. Full compliance not claimed due to lack of diagnostic software provided by manufacturer. Full compliance to IEC 60601-1 and IEC 60601-1-2. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" in the context of diagnostic performance evaluation for a medical device that interprets ECGs. The BT3/6, BT12 device does not interpret ECG data; it merely acquires and transmits it.
The testing mentioned relates primarily to hardware safety and performance standards. The submission states: "The BT3/6, BT12 has been tested according to IEC 60601-1 and IEC 60601-1-2 by accredited laboratories and has shown full compliance to these standards and the standards listed in chapter 9 of this 510(k)." This refers to engineering and electrical safety testing, not clinical studies with patient data to evaluate diagnostic accuracy.
Therefore, there is no information on:
- Sample size for a clinical test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As the device does not interpret ECG data, there was no need for experts to establish ground truth for a diagnostic test set. The device's function is to accurately acquire and transmit the raw ECG signal.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication in the context of diagnostic performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a wireless ECG acquisition and transmission device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or performed in the context of reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device's primary function is signal acquisition and transmission, not algorithmic interpretation by itself. Its performance is evaluated on its ability to accurately capture and transmit the raw ECG signal according to technical specifications, not on a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for diagnostic ground truth. The "ground truth" for this device would be its adherence to technical specifications and standards for signal integrity, electrical safety, and wireless transmission, as outlined in IEC 60601-1, IEC 60601-1-2, and the hardware aspects of ANSI/AAMI EC11 and EC38. Compliance with these standards by accredited laboratories serves as the "proof" of its foundational performance.
8. The sample size for the training set
Not applicable. This device is a hardware product for signal acquisition and transmission, not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.
{0}------------------------------------------------
| Title | Premarket Notification for BT |
|---|---|
| Document Name | BT_510(k).doc |
| Issue | 1.1 |
| Date | 11.08.2008 |
| Corscience GmbH & Co. KG |
SEP - 2 2008
5 510(K) SUMMARY
General Information
5.1 Applicant
June 13, 2008 Date:
- Corscience GmbH & Co. KG Name:
- Address: Henkestr. 91 D-91052 Erlangen Germany
Contact person in the U.S .: Address
Telephone: FAX: E-Mail:
Contact person in Germany: Telephone: FAX: E-Mail:
rpkarem@somnotech.com Christine Baumann 01149 9131 977986 - 25 01149 9131 977986 - 59
Patrik R. Karem SOMNO TECH, L.L.C.
700-706 Seco Rd. Monroeville, PA 15146
412 — 372 — 8571
412 - 372 - 8575
Signature:
. Baumann
5.2 Trade Name
BT3/6, BT12
5.3 Common Name or Classification Name
Wireless electrocardiograph
Establishment Registration Number 5.4
3005488716
{1}------------------------------------------------
| Title | Premarket Notification for BT |
|---|---|
| Document Name | BT_510(k).doc |
| Issue | 1.1 |
| Date | 11.08.2008 |
| Corscience GmbH & Co. KG |
K082077 p2/6
5.5 Facility Address
Corscience GmbH & Co. KG Henkestr. 91 D-91052 Erlangen Germany
5.6 Device Classification
5.6.1 Classification
This is a class II device
5.6.2 Classification panel
Panel: cardiovascular Product Code DXH
5.6.3 Regulation Number
870.2920
Reason for Premarket Notification 5.7
Approval of new ECG device.
5.8 Predicate Device Description
5.8.1
CG-7000DX-BT
5.8.2 Predicate Device Company
Card Guard Scientific Survival, LTD.
ર-8.3 Predicate Device 510(k)#
{2}------------------------------------------------
| Document Name | BT_510(k).doc |
|---|---|
| Issue | 1.1 |
| Date | 11.08.2008 |
| Corscience GmbH & Co. KG | K082077 |
| 3/6 |
5.9 Device Description
BT3/6. BT12 is a compact ECG device which is worn on the body and is capable of wireless data transmission. With the BT3/6 type, 2 ECG leads (II - III according to Einthoven) can be measured via a 4-pin cable. The receiving unit can calculate four additional leads (lead I according to Einthoven, aVL, aVR, aVF according to Goldberger).Type BT12 has a 10-pin cable, which, in addition to the leads of the BT3/6 variant, can also measure the 6 leads according to Wilson. With this cable, one can select among 3-, 6- or 12-channel ECG measurements. The cables of the BT are pluggable and therefore can be easily changed.
The electrode clips on the patient cables are suitable for connection to button and tab electrodes. It has an integrated electrode contact detector and a heart rate meter, the results of which are displayed on an integrated LCD display. Thanks to the integrated radio data transmission technology, BT3/6, BT12 is able to transmit ECG data online over a range of up to 10 m to a monitor or recording unit for further evaluation.
BT3/6, BT12 can be used in all medical applications where the long, stiff trunk cables are a problem due to their weight, their motion artifacts or their electromagnetic susceptibility or because they limit the patient in his freedom of motion. Especially significant are the applications in which it is necessary for the patient to move around freely, for example when the patient is undergoing a stress electrocardiogram.
BT3/6, BT12 is compact and simple to operate. A clip allows the device to the patient's clothing. BT3/6, BT12 is powered by two standard AA cells.
Patient contacting components are the electrodes. BT3/6, BT12 is intended for use with approved. biocompatible electrodes only.
A user manual with detailed description of the device is submitted in section 13 "Proposed Labeling".
5.10 Intended Use Statement
The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. The collected data is processed by the BT device and then transmitted via a standard wireless link to a monitoring device, such as a PC or handheld device for display, review, printing, saving and post event processing by medical professionals. Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.).
Measurements taken by the BT devices are only significant if considered in connection with other clinical findings. No therapy or drugs can be administered based solely on ECG data derived from the BT devices. BT devices are not intended for monitoring critical patients and are not intended for intracardial use.
5.11 Required Components
- BT3/6, BT12 .
- . User manual
- Batteries .
- Cable 4-lead (BT3/6 only) �
- Cable 10-lead (BT12 only) .
{3}------------------------------------------------
| Parameter | BT3/6, BT12 | Predicate DeviceCG-7000DX-BT12 Lead ECGRecorder/ Transmitter | ||
|---|---|---|---|---|
| Intended Use | The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the"BT devices", are battery powereddevices capable of acquiring andtransmitting a standardelectrocardiogram (EKG) to beapplied by medically trained personsfor the purpose of cardiac monitoringand diagnosis performed by medicalprofessionals. The collected data isnot interpreted by the BT device asthis is done by the monitoring deviceoperated by medical professionals.The collected data is processed bythe BT device and then transmittedvia a standard wireless link to amonitoring device, such as a PC orhand-held device for display, review,printing, saving and post eventprocessing by medical professionals.Use of the BT devices is notrestricted to adult population, but isalso intended for infants weighingless than 10 kg (22 lbs.).Measurements taken by the BTdevices are only significant ifconsidered in connection with otherclinical findings. No therapy or drugscan be administered based solely onECG data derived from the BTdevices. BT devices are not intendedfor monitoring critical patients andare not intended for intracardial use. | 12-Lead ambulatory electrocardiographcapable of recording and transmittingup to 40 standard ECGs for the purposeof cardiac monitoring and diagnosis,incorporates recording/ transmittingcircuitry, graphic LCD, a package offirmware tools and is intended for useby a medical professional:a. The ECG is recorded and transmittedto a remote receiving stationfor consultation with a cardiologist.b. The ECG is recorded and transferredto a remote hand helddevice/PC/printer for viewing andprocessing. | ||
| ECG interpretationsoftware | No interpretation | No interpretation | ||
| Input dynamic range | +/- 5 mV | +/- 5mV | ||
| Frequency responsebandwidth | 0,05-150Hz / according to EC11 andIEC 60601-2-51 | |||
| Resolution | 24 bit A/D converter(15 bit transmitted)2,58 µV/bit | 10 bit | ||
| Leads | 3/6 or 12 | 12 | ||
| CMRR | >94 dB | 60 dB |
{4}------------------------------------------------
082077 P 5/6
| Title | Premarket Notification for BT |
|---|---|
| Document Name | BT_510(k).doc |
| Issue | 1.1 |
| Date | 11.08.2008 |
| Corscience GmbH & Co. KG |
| Parameter | BT3/6, BT12 | Predicate DeviceCG-7000DX-BT12 Lead ECGRecorder/ Transmitter |
|---|---|---|
| Pacemakerdetection | Yes | Yes |
| Current consumption | For BT12:Operation (incl. transmission):148 mAstand-by: 37 mA | Record: 55 mATransmit: 75 mA |
| Battery type | 2 x 1,5V alkaline or2 x 1,2V rechargeable | 9V alkaline |
| Input impedance | 20 MΩ | > 10 MΩ |
| DC offset correction | ± 190 mV | ± 75 mV |
| ECG storagecapacity | 5 min/12 channel when transmissionis interrupted | 4-20 s length, 40-10 recordings (eventrecorder) |
| Temperature range | Operation: 0...50°CStorage: -20...70°C | Operation: 0...40°CStorage: -20...65°C |
| Display | LCD | LCD |
| Weight | 260 g incl. batteries and cable154 g without batteries, incl. cable | 274 g incl. batteries228 g (without batteries and cable) |
| Dimensions in mm | 61 x 106 x 23 | 168 x 78 x 40 |
| A to D sampling rate | 500 samples/sec | 500 samples/sec |
| data transmission | wireless | wireless |
| Degree of protectionagainst penetrationof water | IPX3 | IPX0 |
| Classification | BF | BF |
| Defibrillationprotection | Device itself is not defibrillationproof, but ECG patient cablesupplied with the device bymanufacturer has defibrillationprotection circuit. Note in manualthat guarantee of defibrillationprotection can be given only incombination with original cable | The CG-7000DX-BT is not adefibrillation-proof device (optionalcable available for defibrillation proofuse). |
Both devices are intended for continuous wireless transmission of ECG signals and both are portable due to battery-supply and light weight. Both devices are capable of acquiring the ECGs at remote sites and transmitting them via radio transmission to an appropriate receiving station. Therefore, the device under consideration and the predicate device are very similar in their basic functions. The predicate device claims conformance with the ECG standards ANSI/AAMI EC11:1991, and ANSI/AAMI EC38:1998. BT3/6, BT12 is conform with hardware requirements of EC11 and EC38. Exception is the offset-voltage requirement of ±300mV. With BT3/6, BT12 an offset of up to ±190mV does not influence the baseline of the ECG signal. But performance is better than that of the predicate device which states DC offset of only ±75 mV.
The differences in technological characteristics between BT3/6, BT12 and the predicate device can be summarized as follows:
{5}------------------------------------------------
The resolution of the BT devices is higher than that of the predicate (15 bit compared to 10 bit) which results in a better ECG signal quality.
The predicate device is available only for the acquisition of 12-lead ECGs, whereas the device under consideration is available for measuring either a 12- or a 3/6-lead ECG (BT12 and BT3/6).
CMRR of the BT devices is higher than with the predicate (>94 db compared to 60 db). This results in a better ECG signal quality in the presence of interference signals.
Input impedance is specified higher with the BT devices (20 MΩ compared to >10 MΩ). Therefore, ECG signal quality is less dependent on electrode contact quality with the BT as with the predicate.
The two devices differ in their data storage functionality. The BT stores data only when the wireless radio connection is interrupted, e.g. when the patient leaves the transmission range. After the connection is re-established the stored data is transmitted to the receiving unit. Interruption of the transmission is indicated on the device. The BT devices are not intended for use as Holter monitors. The CG-7000X-BT has a limited event storage capability of up to 40 ECG recordings.
The BT devices and the predicate are capable of continuously transmitting ECG data.
The graphic display of the CG-7000DX-BT is able to display the measured ECG, while the BT devices can display the ECG on the receiving unit only. But, the predicate is of low resolution and should not be used to make a diagnosis.
The BT devices have a higher degree of protection against penetration of water (IPX3).
5.13 Summary of Device Testing
The BT3/6, BT12 has been tested according to IEC 60601-1 and IEC 60601-1-2 by accredited laboratories and has shown full compliance to these standards and the standards listed in chapter 9 of this 510(k).
BT3/6, BT12 fulfils only those parts of the standards ANSI/AAMI EC11:1991, and ANSI/AAMI EC38:1998 that relate to hardware requirements. In case the device is used in combination with appropriate software and the user manual is adapted to the standards, it is possible to completely comply with these standards. Since the BT3/6, BT12 is supplied without diagnostic/interpreting software, the manufacturer cannot claim full compliance to ANSI/AAMI EC11:1991, and EC38:1998.
The software was tested as described in section 16 "Software". The corresponding FDA software quidelines were followed.
5.14 Conclusions
Based on the above, Corscience GmbH & Co. KG concludes, that BT3/6, BT12 is substantially equivalent to a legally marketed predicate device and iffective for its intended use, and performs as well as or better than the predicate device.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2008
TUV SUD America c/o Mr. Olaf Teichert Third Party Reviewer 1775 Old Highway 8, NW Ste. 104 New Brighton, MN 55112-1891
Re: K082077
Trade/Device Name: BR3/6, BR12 Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: August 13, 2008 Received: August 18, 2008
Dear Mr. Teichert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807);
{7}------------------------------------------------
Page 2 - Mr. Olaf Teichert
labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510/k)
premarket notification. The FDA finding of substantial cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
{8}------------------------------------------------
Food and Drug Administration
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
Indications for Use
| 510(k) Number (if known): | 082077 |
|---|---|
| --------------------------- | -------- |
BT3/6 BT12 Device Name:
1999 1. 16
Indications for Use:
| to adult population, but is also intended for infants weighing less than 10 kg (22 lbs. | The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", arebattery powered devices capable of acquiring and transmitting a standard electrocardiogram(EKG) to be applied by medically trained persons for the purpose of cardiac monitoring anddiagnosis performed by medical professionals. The collected data is processed by the B1device and then transmitted via a standard wireless link to a monitoring device, such as a Por hand-held device for display, review, printing, saving and post event processing by medicalprofessionals. The collected data is not interpreted by the BT device as this is done by themonitoring device operated by medical professionals. Use of the BT devices is not restricted | |
|---|---|---|
| and are not intended for intracardial use. | Measurements taken by the BT devices are only significant if considered in connection withother clinical findings. No therapy or drugs can be administered based solely on ECG dataderived from the BT devices. The BT devices are not intended for monitoring critical patients | |
| Federal law restricts this device to sale by or on the order of a physician. | ||
| Prescription UsePart 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
| NEFIDED | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF | |
| Concurrence of CDRH | vice Evaluation (ODE) | |
| (Division SiantDivision of Cardiovascular Device | ||
| 510(k) Number_ | K082077 | |
| http://www.fda.gov/cdrh/ode/indicate.html | 15 .07.08.2008 |
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).