The following data is part of a premarket notification filed by Vasamedics, L.l.c. with the FDA for Trimflo Parenchymal Blood Flow Monitoring Probe Kit.
| Device ID | K961368 |
| 510k Number | K961368 |
| Device Name: | TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | VASAMEDICS, L.L.C. 2963 YORKTON BLVD. Saint Paul, MN 55117 -1064 |
| Contact | Douglas G Tomasko |
| Correspondent | Douglas G Tomasko VASAMEDICS, L.L.C. 2963 YORKTON BLVD. Saint Paul, MN 55117 -1064 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-09 |
| Decision Date | 1996-10-11 |
| Summary: | summary |