The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Periflux Pf-2.
| Device ID | K844631 |
| 510k Number | K844631 |
| Device Name: | PERIFLUX PF-2 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Contact | Mark T Sandrini |
| Correspondent | Mark T Sandrini MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-27 |
| Decision Date | 1985-02-20 |