SURECALL EMG LABOR MONITOR— 510(k) K090145

Name: FDA 510(k) clearance K090145
Creator: U.S. Food and Drug Administration
Published: 2011-01-25

Substantially Equivalent

Reproductive Research Technologies, LP

FDA 510(k) clearance K090145 for SURECALL EMG LABOR MONITOR, Substantially Equivalent on 2011-01-25. Applicant: Reproductive Research Technologies, LP. Device class: 2.

Clearance details

Applicant: Reproductive Research Technologies, LP
Product code: Code OSP
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 2009-01-21
Decision date: 2011-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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