The following data is part of a premarket notification filed by Applied Biometrics, Inc. with the FDA for Extravascular Doppler (evd) Ultra Blood Flow Probe.
| Device ID | K911320 |
| 510k Number | K911320 |
| Device Name: | EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE |
| Classification | Transducer, Ultrasonic |
| Applicant | APPLIED BIOMETRICS, INC. 6269 BURY DR. Eden Prairie, MN 55346 |
| Contact | Claire T Hovland |
| Correspondent | Claire T Hovland APPLIED BIOMETRICS, INC. 6269 BURY DR. Eden Prairie, MN 55346 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-26 |
| Decision Date | 1991-12-18 |