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FDA 510(k)

BIOFEEDBACK BIO 80

K-Number: K803099 · 1981-03-02

ApplicantBimed, Inc.
Decision Date1981-03-02
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOFEEDBACK BIO 80 is the device name listed in this FDA 510(k) record. The listed applicant is Bimed, Inc.. It received FDA 510(k) clearance on 1981-03-02 under 510(k) number K803099. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFEEDBACK BIO 80?

BIOFEEDBACK BIO 80 is a medical device that received FDA 510(k) clearance on 1981-03-02. The listed applicant is Bimed, Inc.. The 510(k) number is K803099.

When did BIOFEEDBACK BIO 80 receive FDA 510(k) clearance?

BIOFEEDBACK BIO 80 received FDA 510(k) clearance on 1981-03-02, under 510(k) number K803099.

Who is the listed applicant for BIOFEEDBACK BIO 80?

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

What is the FDA product code for BIOFEEDBACK BIO 80?

The FDA product code for BIOFEEDBACK BIO 80 is HCC.

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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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