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FDA 510(k)

ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK

K-Number: K060321 · 2006-05-15

ApplicantAmerican Diagnostic Corp.
Decision Date2006-05-15
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 2006-05-15 under 510(k) number K060321. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK?

ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK is a medical device that received FDA 510(k) clearance on 2006-05-15. The listed applicant is American Diagnostic Corp.. The 510(k) number is K060321.

When did ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK receive FDA 510(k) clearance?

ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK received FDA 510(k) clearance on 2006-05-15, under 510(k) number K060321.

Who is the listed applicant for ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK?

The FDA 510(k) record lists American Diagnostic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK?

The FDA product code for ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK is DQD.

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Other records listing American Diagnostic Corp. as applicant

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K162589Adscope 658 Electronic StethoscopeK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSK012304ADC 656 ELECTRONIC STETHOSCOPEK962655ANEROID AND MERCURIAL SPHYGMOMANOMETERSK940686ELECTRONIC THERMOMETERSK935944PROSCOPES AND ADSCOPES

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Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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