FETAL MONITORING SPIRAL ELECTRODE— 510(k) K905130

Name: FDA 510(k) clearance K905130
Creator: U.S. Food and Drug Administration
Published: 1991-01-29

Substantially Equivalent

Graphic Controls Corp.

FDA 510(k) clearance K905130 for FETAL MONITORING SPIRAL ELECTRODE, Substantially Equivalent on 1991-01-29. 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: 1990-11-15
Decision date: 1991-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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