NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE— 510(k) K110291

Name: FDA 510(k) clearance K110291
Creator: U.S. Food and Drug Administration
Published: 2011-06-17

Substantially Equivalent

Smart Medical Systems , Ltd.

FDA 510(k) clearance K110291 for NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE, Substantially Equivalent on 2011-06-17. Applicant: Smart Medical Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Smart Medical Systems , Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2011-02-01
Decision date: 2011-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Raanana, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.