SMARTPILL GI MONITORING SYSTEM— 510(k) K053547

Name: FDA 510(k) clearance K053547
Creator: U.S. Food and Drug Administration
Published: 2006-07-18

Substantially Equivalent

The Smartpill Corporation

FDA 510(k) clearance K053547 for SMARTPILL GI MONITORING SYSTEM, Substantially Equivalent on 2006-07-18. Applicant: The Smartpill Corporation. Device class: 2.

Clearance details

Applicant: The Smartpill Corporation
Product code: Code NYV
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2005-12-20
Decision date: 2006-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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