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FDA 510(k)

THE FM-212A BIOFEEDBACK UNIT

K-Number: K861950 · 1987-04-22

ApplicantHosa Technology, Inc.
Decision Date1987-04-22
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE FM-212A BIOFEEDBACK UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Hosa Technology, Inc.. It received FDA 510(k) clearance on 1987-04-22 under 510(k) number K861950. 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 THE FM-212A BIOFEEDBACK UNIT?

THE FM-212A BIOFEEDBACK UNIT is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is Hosa Technology, Inc.. The 510(k) number is K861950.

When did THE FM-212A BIOFEEDBACK UNIT receive FDA 510(k) clearance?

THE FM-212A BIOFEEDBACK UNIT received FDA 510(k) clearance on 1987-04-22, under 510(k) number K861950.

Who is the listed applicant for THE FM-212A BIOFEEDBACK UNIT?

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

What is the FDA product code for THE FM-212A BIOFEEDBACK UNIT?

The FDA product code for THE FM-212A BIOFEEDBACK UNIT 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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