K122943 is an FDA 510(k) clearance for the MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER. This device is classified as a Probe, Blood-flow, Extravascular (Class II - Special Controls, product code DPT).
Submitted by Moor Instruments, Ltd. (Axminster, Devon, GB). The FDA issued a Cleared decision on January 3, 2013, 101 days after receiving the submission on September 24, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2120.
| 510(k) Number | K122943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2012 |
| Decision Date | January 03, 2013 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPT — Probe, Blood-flow, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2120 |