FETALFLEX FETAL ELECTRODE— 510(k) K871079

Name: FDA 510(k) clearance K871079
Creator: U.S. Food and Drug Administration
Published: 1987-07-13

Substantially Equivalent

Epcom Medical Systems, Inc.

FDA 510(k) clearance K871079 for FETALFLEX FETAL ELECTRODE, Substantially Equivalent on 1987-07-13. Applicant: Epcom Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Epcom Medical Systems, Inc.
Product code: Code HGP
Device class: Class 2
Regulation: 21 CFR 884.2675
Advisory panel: Obstetrics/Gynecology
Date received: 1987-03-18
Decision date: 1987-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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