(288 days)
It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm44cm (8.7in17.3in)) is wrapped around the single upper arm.
Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
This device is an Arm automatic blood pressure monitor, and the provided text describes its substantial equivalence to a predicate device, rather than presenting a standalone study with acceptance criteria and performance metrics in the typical sense of AI/ML device studies. This document is a 510(k) summary from the FDA.
However, I can extract the relevant "acceptance criteria" for blood pressure measurement accuracy based on the provided specifications, and then infer how it meets these based on the comparison to the predicate device and the referenced standard.
Inference from the text:
The device is an automatic blood pressure monitor that uses an oscillometric technique. The "acceptance criteria" are implied by the accuracy specification listed in the comparison table and the adherence to the IEC 80601-2-30 standard, which defines accuracy requirements for automated sphygmomanometers.
1. A table of acceptance criteria and the reported device performance:
| Criteria Category | Acceptance Criteria (from predicate device specifications) | Reported Device Performance (Implied for Subject Device) |
|---|---|---|
| Measurement Accuracy (Pressure) | ±3mmHg (±0.4kPa) | The subject device is identical in measurement principle and algorithm, and based on substantial equivalence, is implied to also meet ±3mmHg (±0.4kPa) accuracy. |
| Measurement Accuracy (Pulse) | ±5% | The subject device is identical in measurement principle and algorithm, and based on substantial equivalence, is implied to also meet ±5% accuracy. |
| Measurement Range (Pressure) | 0mmHg | Identical to predicate device. |
| Measurement Range (Pulse) | 40 bpm ~ 180 bpm | Identical to predicate device. |
| Intended Use | Measure systolic, diastolic BP, and pulse rate of an adult individual using non-invasive oscillometric technique with cuff (22-44cm) on upper arm. Over-The-Counter use. | Identical to predicate device. |
| Regulatory Standards | Adherence to IEC 80601-2-30 (specifically 2009 & A1:2013) | Confirmed by manufacturer's statement: "tested met all relevant requirements of the aforementioned tests." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document explicitly states: "Therefore repeated clinical test in accordance with the standard IEC 80601-2-30:2009 & A1:2013 is unnecessary." This indicates that no new clinical test set was used for the subject device to re-evaluate its accuracy for blood pressure measurement. Instead, substantial equivalence was established based on the technical similarity to the predicate device, which would have undergone clinical testing to meet the IEC 80601-2-30 standard. The IEC 80601-2-30 standard typically requires a clinical validation study with a specified number of subjects (e.g., at least 85 subjects for validation, including sufficient numbers in different blood pressure ranges). However, the specific sample size for the predicate is not provided in this document.
- Data Provenance: Not applicable for a new clinical test set for the subject device because it was deemed unnecessary. For the predicate device's validation (which the subject device is relying upon for clinical accuracy), the provenance is not detailed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no new clinical test set was performed for the subject device. For the predicate device's validation, the IEC 80601-2-30 standard requires a specific methodology for reference measurements, typically involving trained observers using a mercury sphygmomanometer or auscultation, but the exact number and qualifications of experts for the predicate's original study are not specified here.
4. Adjudication method for the test set:
- Not applicable as no new clinical test set was performed for the subject device. For the predicate device's validation, the IEC 80601-2-30 standard details the requirements for obtaining reference blood pressure measurements (ground truth), which often involves multiple observers and a consensus or averaging approach.
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 standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The device is an "automatic blood pressure monitor" that uses an "oscillometric technique" and "software calculates the systolic and diastolic blood pressure and pulse rate." This is a standalone algorithm (device) performance measurement. The accuracy criteria (Pressure: ±3mmHg, Pulse: ±5%) are for this standalone performance. The document states that because the technical aspects influencing blood pressure measurement were identical to the predicate, a repeated clinical test was unnecessary, meaning the standalone performance of the subject device is considered to meet the same accuracy standards as the predicate, which would have been established through a standalone clinical validation.
7. The type of ground truth used:
- For the clinical validation implied by adherence to IEC 80601-2-30, the ground truth for blood pressure measurements is typically established through auscultation by trained observers using a reference standard like a mercury sphygmomanometer. This involves direct physiological measurement.
8. The sample size for the training set:
- Not applicable in the context of typical AI/ML training sets. This device uses a "pressure vibration method" and a "software algorithm" for calculation, but the document does not describe it as an AI/ML device that requires a distinct "training set" for model development in the machine learning sense. The algorithm would have been developed and fine-tuned based on engineering principles and potentially clinical data, but not referred to as a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as no described training set in the AI/ML sense. The algorithm's development would follow standard medical device software engineering practices, with performance validated against reference physiological measurements based on established medical standards (e.g., auscultation).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2017
Shenzhen Pump Medical System Co., Ltd. Ms. Migo Yang Clinical Registration Specialist 2/f West, M-7 Sinosteel Building, Maqueling Estate Hi-tech Industrial Park Nanshan District, Shenzhen, 518057 CN
Re: K161712
Trade/Device Name: Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 23, 2016 Received: June 21, 2016
Dear Ms. Migo Yang.
This letter corrects our substantially equivalent letter of April 5, 2017.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Migo Yang
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); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mada Yellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161712
Device Name
Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6055B;
Indications for Use (Describe)
It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable sizes: 22cm44cm (8.7in17.3in)) is wrapped around the single upper arm.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K161712
Submitter's Identification: 1.
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Contact: Xie Qiongyu Tel:86-0755-26710795 Fax:86-0755-26498210 E-mail: xieqy@bpump.com.cn
2. Name of the Device:
Trade Name: Arm automatic blood pressure monitor Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; Regulation Description: Non-invasive blood pressure measurement system. Regulation Number: 21 CFR 870.1130 Regulation Class: II Product Code: DXN Review Panel: Cardiovascular
3. Information for the 510(k) Cleared Device(Predicate device):
Arm automatic blood pressure monitor, Model: BE6034, BE6134, K151258, SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
4. Description of the device
Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
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The arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; has the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
5. Intended Use:
Arm automatic blood pressure monitor, model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter.
6. Indications for Use:
Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; is intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm.
7. Comparison to the 510(k) Cleared Device (Predicate device):
The subject device, Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B;and the predicate device: Arm automatic blood pressure monitor. Model: BE6034, BE6134 uses the same oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Upper arm cuff is inflated automatically by air pump and the pressures are transferred via tubing to a sensor in the unit.
They differ by the appearance , the Bluetooth function and the way of energy supply. The appearance of subject device is a little different from predicate device; The appearance of subject device has Bluetooth function while the subject device has not the Bluetooth function. The only way of energy supply of predicate device is battery while the way of energy supply of subject device can be both battery and adapter. But those differences do not affect the accuracy or normal use of this device because they use the same fundamental scientific technology based on clinical declaration of identity and the declaration of clinical identity.
The subject device: Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; uses the same oscillometric method as the predicate device: Arm automatic blood pressure monitor, Model: BE 6034, BE6134 to determinate the systolic and diastolic blood pressure and pulse rate. They have the same intended use. Based upon the aforementioned information, these devices are substantially equivalent.
Please refer to table below for comparison.
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| No | Items | Model | |||||
|---|---|---|---|---|---|---|---|
| BE6034, BE6134 | BF3213(0B) | BF1214(0B) | BF6123A | BF6148A | BF6055B | ||
| 1 | Manufacturer | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. |
| 2 | Intended Use | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adultindividual byusing a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate ofan adultindividual byusing a non-invasiveoscillometrictechnique inwhich aninflatable cuff(availablesizes: 22cm to44cm (8.7in to17.3in)) iswrappedaround thesingle upperarm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to17.3in)) iswrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to17.3in)) iswrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrappedaround the singleupper arm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate ofan adultindividual byusing a non-invasiveoscillometrictechnique inwhich aninflatable cuff(availablesizes: 22cm to44cm (8.7in to17.3in)) iswrappedaround thesingle upperarm. |
| 3 | Indications forUse | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate of | It is intendedfor measuringsystolic,diastolic bloodpressure and | It is intended formeasuringsystolic,diastolic bloodpressure and | It is intended formeasuringsystolic,diastolic bloodpressure and | It is intended formeasuringsystolic,diastolic bloodpressure and | It is intendedfor measuringsystolic,diastolic bloodpressure and |
| Items | Model | ||||||
| No | BE6034, BE6134 | BF3213(0B) | BF1214(0B) | BF6123A | BF6148A | BF6055B | |
| an adult over thecounter. | pulse rate ofan adult overthe counter. | pulse rate of anadult over thecounter. | pulse rate of anadult over thecounter. | pulse rate of anadult over thecounter. | pulse rate ofan adult overthe counter. | ||
| 4 | Patientpopulation | Adult | Adult | Adult | Adult | Adult | Adult |
| 5 | Environmentof use | Home | Home | Home | Home | Home | Home |
| 6 | MeasuringPrinciple | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod |
| 7 | MeasurementRange | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg |
| 8 | Accuracy | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4 Pa)Pulse: ±5% | Pressure:±3mmHg(±0.4 Pa)Pulse: ±5% | Pressure:±3mmHg(±0.4 Pa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% |
| 9 | Display | TN-LCD DigitalDisplay | TN-LCDDigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCDDigitalDisplay |
| 10 | Memory | 2 Memory sets, 60readings each set. | 2 Memorysets, 60readings eachset. | 2 Memory sets, 60 readingseach set. | 2 Memory sets, 60 readings eachset. | 2 Memory sets, 60 readings eachset. | 2 Memorysets, 60readings eachset. |
| 11 | Power Source | 4 AA Alkalinebattery | 4 AA Alkalinebattery orAC Adapter(Input: AC100-240 V,50/60Hz,400mAOutput: | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA: Output : D.C. | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA: Output : D.C. | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA: Output : D.C. | 4 AA Alkalinebattery orAC Adapter(Input: AC100-240 V,50/60Hz,400mA: Output : |
| No | Items | Model | |||||
| BE6034, BE6134 | BF3213(0B) | BF1214(0B) | BF6123A | BF6148A | BF6055B | ||
| D.C. 6.0V,0.5A;) | 6.0V, 0.5A;) | 6.0V, 0.5A;) | 6.0V, 0.5A;) | D.C. 6.0V,0.5A;) | |||
| 12 | BroadcastFunction | BE6034: YES;BE6134: No | No | No | No | No | |
| 13 | OperatingEnvironment | Temperature:+5°C~+40°C;Humidity: 15%-93%Pressure:70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5°C~+40°C;Humidity:15%-93%Pressure:70.0kPa~106.0kPaAltitude: ≤ 3000 m | Temperature:+5°C~+40°C;Humidity:15%-93%Pressure:70.0kPa~106.0kPaAltitude: ≤ 3000 m | Temperature:+5°C~+40°C;Humidity:15%-93%Pressure:70.0kPa~106.0kPaAltitude: ≤ 3000 m | Temperature:+5°C~+40°C;Humidity:15%-93%Pressure:70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5°C~+40°C;Humidity:15%-93%Pressure:70.0kPa~106.0kPaAltitude: ≤ 3000 m |
| 14 | Storage andTransportEnvironment | Temperature:-25°C~+70°C;Humidity:10%~95%Pressure: 50.0kPa~106.0kPa | Temperature:-25°C~+70°C;Humidity:10%~95%Pressure: 50.0kPa~106.0kPa | Temperature:-25°C~+70°C;Humidity:10%~95%Pressure: 50.0kPa~106.0kPa | Temperature:-25°C~+70°C;Humidity:10%~95%Pressure: 50.0kPa~106.0kPa | Temperature:-25°C~+70°C;Humidity:10%~95%Pressure: 50.0kPa~106.0kPa | Temperature:-25°C~+70°C;Humidity:10%~95%Pressure: 50.0kPa~106.0kPa |
| 15 | Weight | 360g (Withoutbatteries) | 278g(withoutbatteries) | 355g(withoutbatteries) | 341g(withoutbatteries) | 342g(withoutbatteries) | 381g(withoutbatteries) |
| 16 | Size | 140mm×116mm×81mm | 138mm×110mm×68mm | 140mm×116mm×81mm | 154mm×124mm×65mm | 141mm×114mm×67mm | 157mm×113mm×60mm |
| 17 | Bluetoothfunction | No | Yes | Yes | Yes | Yes | Yes |
| 18 | Algorithm | Identical | Identical | Identical | Identical | Identical | Identical |
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K161712
The product specification of subject device is identical in Intended Use, Indication for Use, Patient population, Environment of use, Measuring Principle, Measurement Range, Operating Environment, Storage and Transport Environment;
The subject device and predicate device are similar in Display, Broadcast Function: BF3213(0B) has 85×57(mm) standard screen; BE6034, BE6134 BF1214(0B), BF6123A, BF6055B has 94×80(mm) supersize screen; Model BE6034 has Broadcast Function; BE6134, BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B does not have Broadcast Function: But the minor discrepancies mentioned above do not affect the safety or effectiveness of the device.
The subject device and predicate device are differing in Power Source, Weight, Size; Comparing to the subject device has additional power Adapter; Besides, the subject device also has different appearance, which result in different weight and size; But the differences mentioned above do not affect the safety or effectiveness of the device.
The subject device are Substantially Equivalent (SE) to the predicate device which are US legally market devices.
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8. Discussion of Non Clinical tests Performed for Determination of Substantial Equivalence: are as follows:
Testing information demonstrating substantial equivalence to the predicate device and safety and effectiveness of the Arm automatic blood pressure monitor, model: BF3213(0B), BF1214(0B), BF6123B, BF6148B, BF6155B; in the intended environment of use is supported by testing that was conducted in accordance with the FDA guidance "Reviewer Guidance for Premarket Notification Submissions", which outlines Electrical, Mechanical and Environmental Performance requirements.
The following testing was conducted:
- a. IEC 60601-1 Test
- b. IEC 60601-1-2 Test
- c. IEC 60601-1-11 Test
- d. IEC 80601-2-30 Test
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B B; tested met all relevant requirements of the aforementioned tests.
9. Discussion of Clinical Tests Performed
The subject device: Arm automatic blood pressure monitor, Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B; are identical to the predicate device: Arm automatic blood pressure monitor, Model: BE6034, BE6134 from the technical point of view. The differences between them do not relate to blood pressure measurement technology, so the clinical accuracy in terms of blood pressure detection will not be affected. Therefore repeated clinical test in accordance with the standard IEC 80601-2-30:2009 & A1:2013 is unnecessary.
10. Software Information
Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
11. Conclusion
We have demonstrated that there are no significant differences between the subject device: Arm automatic blood pressure monitor (Model: BF3213(0B), BF1214(0B), BF6123A, BF6148A, BF6055B;), and the predicate device: Arm automatic blood pressure monitor (Model: BE6034, BE6134), in terms of safety and effectiveness based on electrical, mechanical and environmental test results per the FDA guidance "Non-Invasive Blood Pressure (NIBP) Monitor Guidance", and the IEC 80601-2-30:2009 + A1:2013.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).