The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Cephalic Doppler W/ultramark 9 Ultrasound System.
| Device ID | K901329 |
| 510k Number | K901329 |
| Device Name: | CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Terrence J Sweeney |
| Correspondent | Terrence J Sweeney ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-21 |
| Decision Date | 1990-11-23 |