The following data is part of a premarket notification filed by Rimed Ltd. with the FDA for Intra-view Bilateral Transcranial Doppler Device, Smart-lite Portable Bilateral Transcranial Doppler Device, Compact Mod.
| Device ID | K974588 |
| 510k Number | K974588 |
| Device Name: | INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | RIMED LTD. P.O.B. 454 Ginot Shomron, IL 44853 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein RIMED LTD. P.O.B. 454 Ginot Shomron, IL 44853 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-09 |
| Decision Date | 1998-08-07 |