MODIFICATION TO FETAL ASSIST— 510(k) K020390

Name: FDA 510(k) clearance K020390
Creator: U.S. Food and Drug Administration
Published: 2002-04-19

Substantially Equivalent

Huntleigh Diagnostics , Ltd.

FDA 510(k) clearance K020390 for MODIFICATION TO FETAL ASSIST, Substantially Equivalent on 2002-04-19. Applicant: Huntleigh Diagnostics , Ltd.. Device class: 2.

Clearance details

Applicant: Huntleigh Diagnostics , Ltd.
Product code: Code LQK
Device class: Class 2
Regulation: 21 CFR 884.2730
Advisory panel: Obstetrics/Gynecology
Date received: 2002-02-06
Decision date: 2002-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

Download summary PDF View on FDA.gov ↗

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