The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Fetal Doppler For Ultramark 4 And 8.
| Device ID | K881329 |
| 510k Number | K881329 |
| Device Name: | FETAL DOPPLER FOR ULTRAMARK 4 AND 8 |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | John Dellinger |
| Correspondent | John Dellinger ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-30 |
| Decision Date | 1989-04-14 |