The following data is part of a premarket notification filed by Perimed, Inc. with the FDA for Periflux System 5000 Modular Laser Doppler System Main Unit Model Pf 5001, Including Pf 5010 Ldpm Unit.
| Device ID | K974285 |
| 510k Number | K974285 |
| Device Name: | PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | PERIMED, INC. 821 WEST JERICHO TURNPIKE STE. A Smithtown, NY 11787 |
| Contact | Kjell Bakken |
| Correspondent | Kjell Bakken PERIMED, INC. 821 WEST JERICHO TURNPIKE STE. A Smithtown, NY 11787 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-14 |
| Decision Date | 1998-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332834000714 | K974285 | 000 |
| 07332834000219 | K974285 | 000 |
| 07332834000400 | K974285 | 000 |
| 07332834000417 | K974285 | 000 |
| 07332834000424 | K974285 | 000 |
| 07332834000486 | K974285 | 000 |
| 07332834000493 | K974285 | 000 |
| 07332834000523 | K974285 | 000 |
| 07332834000592 | K974285 | 000 |
| 07332834000691 | K974285 | 000 |
| 07332834000608 | K974285 | 000 |