The following data is part of a premarket notification filed by Applied Biometrics, Inc. with the FDA for Abcom 1 Cardiac Output Monitor.
| Device ID | K870857 |
| 510k Number | K870857 |
| Device Name: | ABCOM 1 CARDIAC OUTPUT MONITOR |
| Classification | Transducer, Ultrasonic |
| Applicant | APPLIED BIOMETRICS, INC. 14873 DEVEAU PLACE Minnetonka, MN 55345 |
| Contact | Claire T Hovland |
| Correspondent | Claire T Hovland APPLIED BIOMETRICS, INC. 14873 DEVEAU PLACE Minnetonka, MN 55345 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-11-16 |