LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE— 510(k) K943732

Name: FDA 510(k) clearance K943732
Creator: U.S. Food and Drug Administration
Published: 1994-10-20

Substantially Equivalent

Graphic Controls Corp.

FDA 510(k) clearance K943732 for LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE, Substantially Equivalent on 1994-10-20. Applicant: Graphic Controls Corp.. Device class: 2.

Clearance details

Applicant: Graphic Controls Corp.
Product code: Code HGP
Device class: Class 2
Regulation: 21 CFR 884.2675
Advisory panel: Obstetrics/Gynecology
Date received: 1994-08-02
Decision date: 1994-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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