The following data is part of a premarket notification filed by Vasamedics, L.l.c. with the FDA for Model Pv2000 Vascular Microlaboratory.
| Device ID | K951486 |
| 510k Number | K951486 |
| Device Name: | MODEL PV2000 VASCULAR MICROLABORATORY |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | VASAMEDICS, L.L.C. 2963 YORKTON BLVD. Saint Paul, MN 55117 -1064 |
| Contact | John Borgos |
| Correspondent | John Borgos VASAMEDICS, L.L.C. 2963 YORKTON BLVD. Saint Paul, MN 55117 -1064 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-30 |
| Decision Date | 1995-06-29 |