The following data is part of a premarket notification filed by Moor Instruments Ltd with the FDA for Moorldi2-ir Infrared Laser Doppler Imager, Moorldi2-hir High Resolution Infrared Laser Doppler Imager, Moorldi2-vr Visible Red Laser Doppler Imager.
| Device ID | K152749 |
| 510k Number | K152749 |
| Device Name: | MoorLDI2-IR Infrared Laser Doppler Imager, MoorLDI2-HIR High Resolution Infrared Laser Doppler Imager, MoorLDI2-VR Visible Red Laser Doppler Imager |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | Moor Instruments Ltd Millwey Rise Axminster, GB Ex13 5hu |
| Contact | Stewart Lillington |
| Correspondent | Stewart Lillington Moor Instruments Ltd Millwey Rise Axminster, 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 | 2015-09-23 |
| Decision Date | 2016-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060484490058 | K152749 | 000 |