The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Moorflpi Full-field Laser Perfusion Imager.
| Device ID | K063586 |
| 510k Number | K063586 |
| Device Name: | MOORFLPI FULL-FIELD LASER PERFUSION IMAGER |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex13 5hu |
| Contact | Xiabing Huang |
| Correspondent | Xiabing Huang MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex13 5hu |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-01 |
| Decision Date | 2007-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060484490034 | K063586 | 000 |