The following data is part of a premarket notification filed by Sync-rx Ltd with the FDA for Sync-rx System, Model As00010.
| Device ID | K100849 |
| 510k Number | K100849 |
| Device Name: | SYNC-RX SYSTEM, MODEL AS00010 |
| Classification | System, X-ray, Angiographic |
| Applicant | SYNC-RX LTD 555 ZANG ST SUITE 100 Lakewood, CO 80228 |
| Contact | A Anselmo |
| Correspondent | A Anselmo SYNC-RX LTD 555 ZANG ST SUITE 100 Lakewood, CO 80228 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-26 |
| Decision Date | 2010-05-21 |
| Summary: | summary |