The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Moorflpi-2 Full-field Laser Perfusion Imager.
| Device ID | K122943 |
| 510k Number | K122943 |
| Device Name: | MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex135hu |
| Contact | Stewart Lillington |
| Correspondent | Stewart Lillington MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex135hu |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2013-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060484490157 | K122943 | 000 |
| 15060484490126 | K122943 | 000 |
| 15060484490119 | K122943 | 000 |
| 15060484490041 | K122943 | 000 |