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FDA 510(k)

BIOMATT-1

K-Number: K841392 · 1985-01-18

ApplicantBiorec Us, Inc.
Decision Date1985-01-18
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIOMATT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Biorec Us, Inc.. It received FDA 510(k) clearance on 1985-01-18 under 510(k) number K841392. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMATT-1?

BIOMATT-1 is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Biorec Us, Inc.. The 510(k) number is K841392.

When did BIOMATT-1 receive FDA 510(k) clearance?

BIOMATT-1 received FDA 510(k) clearance on 1985-01-18, under 510(k) number K841392.

Who is the listed applicant for BIOMATT-1?

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

What is the FDA product code for BIOMATT-1?

The FDA product code for BIOMATT-1 is BZQ.

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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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