ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK

K060321 · American Diagnostic Corp. · DQD · May 15, 2006 · Cardiovascular

Device Facts

• Record ID: K060321
• Device Name: ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
• Applicant: American Diagnostic Corp.
• Product Code: DQD · Cardiovascular
• Decision Date: May 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended 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.

Device Story

Adscope 657BK is an electronic stethoscope used by clinicians for auscultation. Device captures acoustic body sounds (heart, lung, other) via a chest piece; amplifies signals; allows user selection of frequency ranges. Output is audible sound delivered to clinician via headset. Used in clinical settings for physical assessment; aids in diagnostic decision-making by enhancing sound clarity. Benefits include improved detection of subtle physiological sounds compared to traditional acoustic stethoscopes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic stethoscope; amplifies heart, lung, and body sounds; features selective frequency filtering; handheld form factor; battery-powered; intended for clinical diagnostic use.

Indications for Use

Indicated for medical diagnostic purposes, specifically the amplification of heart, lung, and other body sounds during physical assessment of any patient.

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

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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 [phone]. 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 [phone] or [phone] 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):

K060321

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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