The following data is part of a premarket notification filed by Perimed, Inc. with the FDA for Periflux Pf4001 Laser Doppler Flowmeter.
| Device ID | K922368 |
| 510k Number | K922368 |
| Device Name: | PERIFLUX PF4001 LASER DOPPLER FLOWMETER |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | PERIMED, INC. 200 CENTENNIAL AVE. Piscataway, NJ 08854 -3910 |
| Contact | Oystein Lind |
| Correspondent | Oystein Lind PERIMED, INC. 200 CENTENNIAL AVE. Piscataway, NJ 08854 -3910 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-20 |
| Decision Date | 1993-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332834000349 | K922368 | 000 |
| 07332834000332 | K922368 | 000 |