NAVIAID(TM) BGC DEVICE


Device Classification Name

endoscope channel accessory

510(k) Number K111760
Device Name NAVIAID(TM) BGC DEVICE
Applicant
SMART MEDICAL SYSTEMS, LTD.
10 hayetsira street
raanana, 

IL

43663

Applicant Contact adva yoselzon
Correspondent
SMART MEDICAL SYSTEMS, LTD.
10 hayetsira street
raanana, 

IL

43663

Correspodent Contact adva yoselzon
Regulation Number 876.1500
Classification Product Code
ODC  
Date Received 06/22/2011
Decision Date 08/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No