(82 days)
Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices. It is intended that the Cardiostation will be used by physicians and cardiac laboratories supervised by physicians.
Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, or study details. This document appears to be an FDA 510(k) clearance letter for a device called "Cardiostation," primarily focusing on its substantial equivalence to a predicate device and its indications for use. It does not include a study report or performance data.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1998
Universal Medical, Inc. Mr. Douglas M. Lurio c/o.Lurio & Associates 1608 Walnut Street Sixth Floor Philadelphia, PA 19103
Re: K980624 Cardiostation Regulatory Class: II (two) Product Code: 74 DXH February 13, 1998 Dated: Received: February 18, 1998
Dear Mr. Lurio:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part. 820) and that, through periodic QS_.. . inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahar Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): not known
Device Name: Cardiostation
Indications For Use:
Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices. It is intended that the Cardiostation will be used by physicians and cardiac laboratories supervised by physicians.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED:
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------onto was cam and area sum and and Concurrence of CDHR, Office of Device Devaluation (ODE)
Prescription Use x (Per 21 CFR 801.109) OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
Signature
A
§ 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).