OP3/VP4— 510(k) K924516

Substantially Equivalent

Huntleigh Technology, Inc.

FDA 510(k) clearance K924516 for OP3/VP4, Substantially Equivalent on 1993-06-28. Applicant: Huntleigh Technology, Inc.. Device class: 2.

Clearance details

Applicant: Huntleigh Technology, Inc.
Product code: Code HGL
Device class: Class 2
Regulation: 21 CFR 884.2960
Advisory panel: Obstetrics/Gynecology
Date received: 1992-09-04
Decision date: 1993-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manalapan, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.