NAVIAID(TM) BGC DEVICE— 510(k) K111760

Substantially Equivalent

Smart Medical Systems , Ltd.

FDA 510(k) clearance K111760 for NAVIAID(TM) BGC DEVICE, Substantially Equivalent on 2011-08-09. Applicant: Smart Medical Systems , Ltd..

Clearance details

Applicant: Smart Medical Systems , Ltd.
Product code: Code ODC
Advisory panel: Gastroenterology, Urology
Date received: 2011-06-22
Decision date: 2011-08-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Raanana, IL

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