The following data is part of a premarket notification filed by Rimed Ltd. with the FDA for Digi-lite Tcd Device.
| Device ID | K062578 |
| 510k Number | K062578 |
| Device Name: | DIGI-LITE TCD DEVICE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | RIMED LTD. 20 HATA'AS ST Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein RIMED LTD. 20 HATA'AS ST Kfar Saba, IL 44425 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-31 |
| Decision Date | 2006-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016734065 | K062578 | 000 |
| 07290016734058 | K062578 | 000 |
| 07290016734041 | K062578 | 000 |
| 07290016734003 | K062578 | 000 |