DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00

K991714 · Doctor'S Research Group, Inc. · DQD · Dec 10, 1999 · Cardiovascular

Device Facts

• Record ID: K991714
• Device Name: DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
• Applicant: Doctor'S Research Group, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The DRG Conventional Electronic Digital Stethoscope can be used as a standard stethoscope or as an electronic digital stethoscope. The additional stethoscope features allow the user to digitally record, amplify or replay sounds associated with the heart, artery, veins and other internal organs. The sounds can be replayed at different speeds.

Device Story

Device functions as both standard acoustic stethoscope and electronic digital stethoscope; captures physiological sounds (heart, artery, vein, internal organs) via integrated sensors; electronic module provides amplification, digital recording, and playback capabilities; allows playback at variable speeds; intended for use by healthcare professionals in clinical settings to assist in physical examination and diagnostic assessment; output provided via earpieces for real-time auscultation or digital playback for review.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Electronic digital stethoscope; features include sound amplification, digital recording, and variable speed playback; operates as both acoustic and electronic device; powered by internal electronics; intended for clinical auscultation.

Indications for Use

Indicated for use by clinicians to auscultate, record, amplify, and replay sounds from the heart, arteries, veins, and other internal organs for diagnostic purposes.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I O 1999

Ms. Maureen Regan Doctor's Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716

Re: K991714 DRG Conventional Electronic Digital Stethoscope Requlatory Class: II (two) Product Code: DOD Dated: September 13, 1999 Received: September 20, 1999

Dear Ms. Regan:

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 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). 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 aqainst 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 A substantially equivalent determination assumes compliance to 895. 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 regulation 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 - Ms. Maureen Regan

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

elia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Doctor's Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 [phone]

## Statement of Indications For Use:

510(k) Number (if Known): _ K 991714

Device Name: Conventional Electronic Digital Stethoscope

Indications for use:

The DRG Conventional Electronic Digital Stethoscope can be used as a standard stethoscope or as an electronic digital stethoscope. The additional stethoscope features allow the user to digitally record, amplify or replay sounds associated with the heart, artery, veins and other internal organs. The sounds can be replayed at different speeds.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRG, Office of Device Evaluation (ODE)

Venkattillam

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Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Prescription Use / (Per 21 CFR 801.109)

OR

Over-The-Counter Use