TERM GUARD 5000 UTERINE ACTIVITY— 510(k) K843011

Name: FDA 510(k) clearance K843011
Creator: U.S. Food and Drug Administration
Published: 1984-11-01

Substantially Equivalent

Tokos Medical Corp.

FDA 510(k) clearance K843011 for TERM GUARD 5000 UTERINE ACTIVITY, Substantially Equivalent on 1984-11-01. Applicant: Tokos Medical Corp.. Device class: 2.

Clearance details

Applicant: Tokos Medical Corp.
Product code: Code HFM
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 1984-07-31
Decision date: 1984-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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