INNOVA VAGINAL EMG SENSING ELECTRODE— 510(k) K940091

Substantially Equivalent

Empi

FDA 510(k) clearance K940091 for INNOVA VAGINAL EMG SENSING ELECTRODE, Substantially Equivalent on 1994-12-29. Applicant: Empi. Device class: 2.

Clearance details

Applicant: Empi
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 1994-01-07
Decision date: 1994-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.