The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Cerebrovascular Diagnostic System; Cds.
| Device ID | K914862 |
| 510k Number | K914862 |
| Device Name: | CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDASONICS, INC. 47233 FREMONT BLVD. P.O. BOX 4903 Fremont, CA 94538 |
| Contact | Keith V Rohrbach |
| Correspondent | Keith V Rohrbach MEDASONICS, INC. 47233 FREMONT BLVD. P.O. BOX 4903 Fremont, CA 94538 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1992-12-03 |