Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K101191
Device Name NAVIAID ICVI DEVICE
Applicant
Smart Medical Systems , Ltd.
10 Hayetsira St.
Raanana,  IL 43663
Applicant Contact ADVA YOSELZON
Correspondent
Smart Medical Systems , Ltd.
10 Hayetsira St.
Raanana,  IL 43663
Correspondent Contact ADVA YOSELZON
Regulation Number876.1500
Classification Product Code
FDF  
Date Received04/28/2010
Decision Date 07/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-