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FDA 510(k)

BIOFEEDBACK DEVICE

K-Number: K954127 · 1995-11-14

ApplicantVerimed Holdings, Inc.
Decision Date1995-11-14
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOFEEDBACK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Verimed Holdings, Inc.. It received FDA 510(k) clearance on 1995-11-14 under 510(k) number K954127. 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 DEVICE?

BIOFEEDBACK DEVICE is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Verimed Holdings, Inc.. The 510(k) number is K954127.

When did BIOFEEDBACK DEVICE receive FDA 510(k) clearance?

BIOFEEDBACK DEVICE received FDA 510(k) clearance on 1995-11-14, under 510(k) number K954127.

Who is the listed applicant for BIOFEEDBACK DEVICE?

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

What is the FDA product code for BIOFEEDBACK DEVICE?

The FDA product code for BIOFEEDBACK DEVICE is HCC.

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Other records listing Verimed Holdings, Inc. as applicant

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.

K981277PERIFORMK951969MYOEXORCISER II FUALK930670PHYACTION 787K922550ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)K913912VERIMED PERINEOMETERK893220VERIMED MYOEXORCISER VERISTIM

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Related Devices (Code: HCC)

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.

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Official Source

View on FDA Database →

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

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