(95 days)
The ADSCOPE 657BK Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
Not Found
This document is a 510(k) clearance letter from the FDA for a conventional electronic stethoscope. It does not contain information about acceptance criteria or a study proving device performance as it is not an AI/ML device.
Therefore, I cannot provide the requested information based on the given input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. 5
MAY 15 2006
Mr. Michael Falco American Diagnostics Corporation 55 Commerce Drive Hauppauge, New York 11788
Re: K060321
Trade/Device Name: Adscope 657BK Electronic Stethoscope, Model 657BK Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: II Product Code: DQD Dated: April 28, 2006 Received: April 28, 2006
Dear Mr. Falco
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 r ou may marca 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Michael Falco
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of devilou that I Drinination that your device complies with other requirements of the Act that I Dri has Intatutes and regulations administered by other Federal agencies. You must or uny I ederal bakates the requirements, including, but not limited to: registration and listing Compry with an the Net b requirements, a 801); good manufacturing practice requirements as set (21 CFR Part 607), acoming (21 cegulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) This lotter will anon. The FDA finding of substantial equivalence of your device to a legally premiative nedicate device results in a classification for your device and thus, permits your devi to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you t the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Bfammmer 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):
Device Name: ADSCOPE 657BK Electronic Stethoscope
Indications For Use: The ADSCOPE 657BK Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Bimmuno
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Kqu032!
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§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
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.