The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Moorldls-bi Laser Doppler Burns Imager.
| Device ID | K132163 |
| 510k Number | K132163 |
| Device Name: | MOORLDLS-BI LASER DOPPLER BURNS IMAGER |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex135hu |
| Contact | Xiabing Huang |
| Correspondent | Xiabing Huang 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 | 2013-07-12 |
| Decision Date | 2014-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060484490089 | K132163 | 000 |