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FDA 510(k)

INNOVA VAGINAL EMG SENSING ELECTRODE

K-Number: K940091 · 1994-12-29

ApplicantEmpi
Decision Date1994-12-29
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INNOVA VAGINAL EMG SENSING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1994-12-29 under 510(k) number K940091. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVA VAGINAL EMG SENSING ELECTRODE?

INNOVA VAGINAL EMG SENSING ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Empi. The 510(k) number is K940091.

When did INNOVA VAGINAL EMG SENSING ELECTRODE receive FDA 510(k) clearance?

INNOVA VAGINAL EMG SENSING ELECTRODE received FDA 510(k) clearance on 1994-12-29, under 510(k) number K940091.

Who is the listed applicant for INNOVA VAGINAL EMG SENSING ELECTRODE?

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

What is the FDA product code for INNOVA VAGINAL EMG SENSING ELECTRODE?

The FDA product code for INNOVA VAGINAL EMG SENSING ELECTRODE is HIR.

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Other records listing Empi 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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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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