The following data is part of a premarket notification filed by Smart Medical Systems, Ltd. with the FDA for Naviaid Bge Device, Model 21-001.
| Device ID | K060923 |
| 510k Number | K060923 |
| Device Name: | NAVIAID BGE DEVICE, MODEL 21-001 |
| Classification | Enteroscope And Accessories |
| Applicant | SMART MEDICAL SYSTEMS, LTD. 20 HATA'AS STREET, STE 213 BEIT HAPA'AMON, BOX 124 Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein SMART MEDICAL SYSTEMS, LTD. 20 HATA'AS STREET, STE 213 BEIT HAPA'AMON, BOX 124 Kfar Saba, IL 44425 |
| Product Code | FDA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-04 |
| Decision Date | 2006-08-15 |
| Summary: | summary |