FETAL SCALP SPIRAL ELECTRODE— 510(k) K911657

Name: FDA 510(k) clearance K911657
Creator: U.S. Food and Drug Administration
Published: 1991-07-11

Substantially Equivalent

Advanced Medical Systems, Inc.

FDA 510(k) clearance K911657 for FETAL SCALP SPIRAL ELECTRODE, Substantially Equivalent on 1991-07-11. Applicant: Advanced Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Medical Systems, Inc.
Product code: Code HGP
Device class: Class 2
Regulation: 21 CFR 884.2675
Advisory panel: Obstetrics/Gynecology
Date received: 1991-04-12
Decision date: 1991-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamden, CT, US

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