ELECTROCARDIOGRAPHS
Device Facts
| Record ID | K972587 |
|---|---|
| Device Name | ELECTROCARDIOGRAPHS |
| Applicant | Dr. Lee Co., Ltd. |
| Product Code | LOS · CV |
| Decision Date | Aug 21, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
Indications for Use
Dr.LEE ECG-310A (with interpretive software) is to be used to process the electrical signal transmitted through electrodes and to produce a visual display of the electrical signal produced by the heart. While the Dr.LEE ECG-310A is capable of interpreting the ECG waveform as an aid, it is not intended to replace the review and interpretation by the physician. To be used under professional healthcare supervision.
Device Story
Device: Dr.LEE ECG-310A; electrocardiograph with interpretive software. Input: electrical signals from heart via electrodes. Processing: signal acquisition; waveform interpretation. Output: visual display of ECG waveforms; interpretive analysis. Usage: clinical setting; professional healthcare supervision. Role: aid to physician; not replacement for clinical review. Benefit: assists in cardiac signal visualization and interpretation.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Electrocardiograph; interpretive software; electrode-based signal acquisition; visual display output; professional use.
Indications for Use
Indicated for use under professional healthcare supervision to process electrical signals from the heart via electrodes and provide visual ECG waveform displays and interpretive aid for clinical review.
Related Devices
- K961272 — NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES · Nihon Kohden America, Inc. · Nov 1, 1996
- K073376 — PHILIPS ECG ALGORITHM · Philips Medical Systems · Apr 11, 2008
- K972603 — ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B · Dr. Lee Co., Ltd. · Mar 11, 1998
- K946281 — ECLIPSE 4 ELECTROCARDIOGRAPH · Burdick, Inc. · Apr 23, 1996
- K160746 — CARDIOLINE touchECG · Cardioline S.P.A · Nov 2, 2016
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 1998
Dr. Lee Co., Ltd. c/o Holland & Associates 3722 Avenue, Sausalito Irvine, CA 92606 Attention: Mr. Greg Holland
Re: K972587 Electrocardiograph, Dr. Lee ECG-310A Requlatory Class: III (three) Product Code: 74 LOS Dated: June 4, 1998 Received: June 8, 1998
Dear Mr. Holland:
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 leqally 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). 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 (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 Regulation (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 requlation may result in regulatory 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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Page 2 - Dr. Lee Co., Ltd.
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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. allahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K972587 |
|---------------------------|---------|
|---------------------------|---------|
Device Namc:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
--
Dr.LEE ECG-310A (with interpretive software) is to be used to process the electrical signal transmitted through electrodes and to produce a visual display of the electrical signal produced by the heart. While the Dr.LEE ECG-310A is capable of interpreting the ECG waveform as an aid, it is not intended to replace the review and interpretation by the physician.
To be used under professional healthcare supervision.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|-------------------------------------------------------------------|---------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K972587 |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|
(Optional Format 1-2-96)
