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FDA 510(k)

PHONOANGIOGRAPHIC SPECTRAL ANALYZER

K-Number: K840169 · 1985-03-01

ApplicantBiotronics Instruments
Decision Date1985-03-01
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHONOANGIOGRAPHIC SPECTRAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Biotronics Instruments. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K840169. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHONOANGIOGRAPHIC SPECTRAL ANALYZER?

PHONOANGIOGRAPHIC SPECTRAL ANALYZER is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Biotronics Instruments. The 510(k) number is K840169.

When did PHONOANGIOGRAPHIC SPECTRAL ANALYZER receive FDA 510(k) clearance?

PHONOANGIOGRAPHIC SPECTRAL ANALYZER received FDA 510(k) clearance on 1985-03-01, under 510(k) number K840169.

Who is the listed applicant for PHONOANGIOGRAPHIC SPECTRAL ANALYZER?

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

What is the FDA product code for PHONOANGIOGRAPHIC SPECTRAL ANALYZER?

The FDA product code for PHONOANGIOGRAPHIC SPECTRAL ANALYZER is DPW.

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Related Devices (Code: DPW)

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Official Source

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

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