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FDA 510(k)

SONOPAK/QS, SONOPAK

K-Number: K905657 · 1991-05-15

ApplicantBioresearch
Decision Date1991-05-15
Product CodeNFQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SONOPAK/QS, SONOPAK is the device name listed in this FDA 510(k) record. The listed applicant is Bioresearch. It received FDA 510(k) clearance on 1991-05-15 under 510(k) number K905657. The device is classified under product code NFQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOPAK/QS, SONOPAK?

SONOPAK/QS, SONOPAK is a medical device that received FDA 510(k) clearance on 1991-05-15. The listed applicant is Bioresearch. The 510(k) number is K905657.

When did SONOPAK/QS, SONOPAK receive FDA 510(k) clearance?

SONOPAK/QS, SONOPAK received FDA 510(k) clearance on 1991-05-15, under 510(k) number K905657.

Who is the listed applicant for SONOPAK/QS, SONOPAK?

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

What is the FDA product code for SONOPAK/QS, SONOPAK?

The FDA product code for SONOPAK/QS, SONOPAK is NFQ.

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Related Devices (Code: NFQ)

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.

K970116ESG-1 ELECTROSONOGRAM (ESG-1)Myo-Tronics, Inc.K905449ELECTROSONOGRAM ESG-1Myo-Tronics, Inc.K862286ARTHROPHONOMETERArthrotek, Inc.

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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