The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Transpect Transcranial Doppler.
| Device ID | K872292 |
| 510k Number | K872292 |
| Device Name: | TRANSPECT TRANSCRANIAL DOPPLER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDASONICS, INC. 82 PIONEER WAY P.O. BOX 7268 Mountain View, CA 94042 |
| Contact | William E Mckay |
| Correspondent | William E Mckay MEDASONICS, INC. 82 PIONEER WAY P.O. BOX 7268 Mountain View, CA 94042 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-16 |
| Decision Date | 1987-08-14 |