The following data is part of a premarket notification filed by Smart Medical Systems, Ltd. with the FDA for Naviaid Icvi-f,s,b,r Device.
| Device ID | K112106 |
| 510k Number | K112106 |
| Device Name: | NAVIAID ICVI-F,S,B,R DEVICE |
| Classification | Endoscope Channel Accessory |
| 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 | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2012-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018671603 | K112106 | 000 |
| 07290018671528 | K112106 | 000 |
| 07290018671634 | K112106 | 000 |