The following data is part of a premarket notification filed by Applied Biometrics, Inc. with the FDA for Abcom 2000.
| Device ID | K912562 |
| 510k Number | K912562 |
| Device Name: | ABCOM 2000 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | APPLIED BIOMETRICS, INC. 6269 BURY DR. Eden Prairie, MN 55346 |
| Contact | Claire Hovland |
| Correspondent | Claire Hovland APPLIED BIOMETRICS, INC. 6269 BURY DR. Eden Prairie, MN 55346 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-11 |
| Decision Date | 1992-01-09 |