The following data is part of a premarket notification filed by Rimed Ltd. with the FDA for Digi-one.
| Device ID | K143476 |
| 510k Number | K143476 |
| Device Name: | Digi-One |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | RIMED LTD. 25 HACHAROSHET ST.,P.O.BOX 2402 INDUSTRIAL PARK RAANANA Raanana, IL 4365613 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A. STEIN- REGULATORY AFFAIRS CONSULTING LTD. 20 HATA'AS ST.(POB 124) 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 | 2014-12-05 |
| Decision Date | 2015-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016734027 | K143476 | 000 |