(243 days)
Dr. LEE ECG-110B, 120B and 310B (non-interpretive electrocardiographs) is used to process the electrical signal transmitted through electrocardiograph electrodes to produce a visual display of the electrical signal produced by the heart.
The patient population is any patient requiring an electrocardiograph at the direction of a physician.
The product is to be used in a medical professional environment, such as a doctors office, hospital, medical clinic and the like.
non-interpretive electrocardiographs
This document is a 510(k) premarket notification letter from the FDA to Dr. Lee Co., Ltd. for Electrocardiographs Models 110B, 120B, and 310B. It states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria, detailed device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. It focuses on the regulatory approval process and indications for use.
Therefore, I cannot provide the requested information based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR | | 1998
Dr. Lee Co., Ltd. c/o Holland and Associates 3722 Avenue Sausalito Irvine, CA 92606
Re: K972603 Electrocardiographs Models 110B, 120B, and 310B Regulatory Class: II (two) Product Code: 74 DPS-Dated: December 18, 1997 December 19, 1997 Received:
Dear Dr. Lee:
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 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 requlation (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 requlation 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. Callahan, 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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Dr. LEE Co., Ltd.
Page 1
510(k) Number (if known): K972603
Device Name: Dr. LEE ECG-110B, 120B and 310B
Indications For Use:
Dr. LEE ECG-110B, 120B and 310B (non-interpretive electrocardiographs) is used to process the electrical signal transmitted through electrocardiograph electrodes to produce a visual display of the electrical signal produced by the heart.
The patient population is any patient requiring an electrocardiograph at the direction of a physician.
The product is to be used in a medical professional environment, such as a doctors office, hospital, medical clinic and the like.
(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 K972603
510(k) Number K972603
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use --------
(Optional Format 1-2-96)
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).