SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING— 510(k) K103274

Name: FDA 510(k) clearance K103274
Creator: U.S. Food and Drug Administration
Published: 2011-08-18

Substantially Equivalent

Sentinelle Medical, Inc.

FDA 510(k) clearance K103274 for SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING, Substantially Equivalent on 2011-08-18. Applicant: Sentinelle Medical, Inc.. Device class: 2.

Clearance details

Applicant: Sentinelle Medical, Inc.
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2010-11-05
Decision date: 2011-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

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