The following data is part of a premarket notification filed by Perimed Ab with the FDA for Pf 5050 Pressure Unit, Model Pf 5050.
| Device ID | K011899 |
| 510k Number | K011899 |
| Device Name: | PF 5050 PRESSURE UNIT, MODEL PF 5050 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | PERIMED AB DATAVAGEN 9-A Jarfalla, SE S-175 26 |
| Contact | Bjorn Bakken |
| Correspondent | Bjorn Bakken PERIMED AB DATAVAGEN 9-A Jarfalla, SE S-175 26 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-18 |
| Decision Date | 2001-11-06 |
| Summary: | summary |