The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Moorld12-b1 Laser Doppler Burns Imager.
| Device ID | K060976 |
| 510k Number | K060976 |
| Device Name: | MOORLD12-B1 LASER DOPPLER BURNS IMAGER |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex135hu |
| Contact | David Boggett |
| Correspondent | David Boggett 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 | 2006-04-10 |
| Decision Date | 2007-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060484490072 | K060976 | 000 |