The following data is part of a premarket notification filed by Vasamedics, L.l.c. with the FDA for Modif. Laserflo Blood Perfusion Monitor Model Bpm2.
| Device ID | K912446 |
| 510k Number | K912446 |
| Device Name: | MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | VASAMEDICS, L.L.C. C/O C.G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy VASAMEDICS, L.L.C. C/O C.G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-03 |
| Decision Date | 1991-12-12 |