K131253 is an FDA 510(k) clearance for the PERIFLUX 6000. This device is classified as a Monitor, Carbon-dioxide, Cutaneous (Class II - Special Controls, product code LKD).
Submitted by Perimed AB (Jarfalla, SE). The FDA issued a Cleared decision on October 22, 2013, 173 days after receiving the submission on May 2, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2480.
| 510(k) Number | K131253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2013 |
| Decision Date | October 22, 2013 |
| Days to Decision | 173 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | LKD — Monitor, Carbon-dioxide, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2480 |