The following data is part of a premarket notification filed by Smart Medical Systems, Ltd. with the FDA for Naviaid Icvi Device.
| Device ID | K101191 |
| 510k Number | K101191 |
| Device Name: | NAVIAID ICVI DEVICE |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | SMART MEDICAL SYSTEMS, LTD. 10 HAYETSIRA STREET Raanana, IL 43663 |
| Contact | Adva Yoselzon |
| Correspondent | Adva Yoselzon SMART MEDICAL SYSTEMS, LTD. 10 HAYETSIRA STREET Raanana, IL 43663 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-28 |
| Decision Date | 2010-07-27 |