The following data is part of a premarket notification filed by Perimed, Inc. with the FDA for Periflux Pf3.
| Device ID | K890828 |
| 510k Number | K890828 |
| Device Name: | PERIFLUX PF3 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | PERIMED, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08855 -1327 |
| Contact | Oystein Lind |
| Correspondent | Oystein Lind PERIMED, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08855 -1327 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-21 |
| Decision Date | 1989-06-20 |