EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01— 510(k) K060289

Name: FDA 510(k) clearance K060289
Creator: U.S. Food and Drug Administration
Published: 2006-07-07

Substantially Equivalent

Frontline Medical

FDA 510(k) clearance K060289 for EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01, Substantially Equivalent on 2006-07-07. Applicant: Frontline Medical. Device class: 2.

Clearance details

Applicant: Frontline Medical
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2006-02-06
Decision date: 2006-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Limerick, IE

Download summary PDF View on FDA.gov ↗

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