The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Cw Doppler Static Transducers.
| Device ID | K861109 |
| 510k Number | K861109 |
| Device Name: | CW DOPPLER STATIC TRANSDUCERS |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-25 |
| Decision Date | 1986-07-08 |