FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM— 510(k) K801984

Name: FDA 510(k) clearance K801984
Creator: U.S. Food and Drug Administration
Published: 1980-09-09

Substantially Equivalent

Life Support, Inc.

FDA 510(k) clearance K801984 for FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM, Substantially Equivalent on 1980-09-09. Applicant: Life Support, Inc.. Device class: 2.

Clearance details

Applicant: Life Support, Inc.
Product code: Code HGP
Device class: Class 2
Regulation: 21 CFR 884.2675
Advisory panel: Obstetrics/Gynecology
Date received: 1980-08-19
Decision date: 1980-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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