The following data is part of a premarket notification filed by Perimed Ab with the FDA for Periflux 6000.
| Device ID | K131253 |
| 510k Number | K131253 |
| Device Name: | PERIFLUX 6000 |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | PERIMED AB DATAVAGEN 9 A Jarfalla, SE 17543 |
| Contact | Maria Liljevret |
| Correspondent | Maria Liljevret PERIMED AB DATAVAGEN 9 A Jarfalla, SE 17543 |
| Product Code | LKD |
| Subsequent Product Code | KLK |
| Subsequent Product Code | LPP |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-02 |
| Decision Date | 2013-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332834000820 | K131253 | 000 |
| 07332834000806 | K131253 | 000 |
| 07332834000790 | K131253 | 000 |