The following data is part of a premarket notification filed by Perimed Ab with the FDA for Periflux6000.
| Device ID | K152930 |
| 510k Number | K152930 |
| Device Name: | PeriFlux6000 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | PERIMED AB DATAVAGEN 9A Jarfalla, SE 17543 |
| Contact | Maria Prans Liljevret |
| Correspondent | Jimmy Bakker PERIMED AB DATAVAGEN 9A Jarfalla, SE 17543 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-05 |
| Decision Date | 2016-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332834000134 | K152930 | 000 |
| 07332834000127 | K152930 | 000 |
| 07332834000110 | K152930 | 000 |
| 07332834000103 | K152930 | 000 |
| 07332834000066 | K152930 | 000 |
| 07332834001162 | K152930 | 000 |