The following data is part of a premarket notification filed by Vasamedics, L.l.c. with the FDA for Laserflo(r) Blood Perfusion Monitor (model Bpm2).
| Device ID | K911763 |
| 510k Number | K911763 |
| Device Name: | LASERFLO(R) 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 | 1991-04-19 |
| Decision Date | 1991-08-13 |