SMARTPILL GI MONITORING SYSTEM, VERSION 2.0— 510(k) K092342

Name: FDA 510(k) clearance K092342
Creator: U.S. Food and Drug Administration
Published: 2009-10-30

Substantially Equivalent

The Smartpill Corporation

FDA 510(k) clearance K092342 for SMARTPILL GI MONITORING SYSTEM, VERSION 2.0, Substantially Equivalent on 2009-10-30. 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: 2009-08-04
Decision date: 2009-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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