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FDA 510(k)

MYOMETER EMG BIOFEEDBACK DEVICE

K-Number: K850849 · 1985-05-31

ApplicantPhysio Technology, Inc.
Decision Date1985-05-31
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MYOMETER EMG BIOFEEDBACK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Physio Technology, Inc.. It received FDA 510(k) clearance on 1985-05-31 under 510(k) number K850849. 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 MYOMETER EMG BIOFEEDBACK DEVICE?

MYOMETER EMG BIOFEEDBACK DEVICE is a medical device that received FDA 510(k) clearance on 1985-05-31. The listed applicant is Physio Technology, Inc.. The 510(k) number is K850849.

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

MYOMETER EMG BIOFEEDBACK DEVICE received FDA 510(k) clearance on 1985-05-31, under 510(k) number K850849.

Who is the listed applicant for MYOMETER EMG BIOFEEDBACK DEVICE?

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

What is the FDA product code for MYOMETER EMG BIOFEEDBACK DEVICE?

The FDA product code for MYOMETER EMG BIOFEEDBACK DEVICE is HCC.

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Other records listing Physio Technology, 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.

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Related Devices (Code: HCC)

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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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