The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Moorvms-ldf1 And Moorvms-ldf2 Laser Doppler Perfusion And Temperature Monitors.
| Device ID | K083082 |
| 510k Number | K083082 |
| Device Name: | MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-16 |
| Decision Date | 2009-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060484490133 | K083082 | 000 |
| 15060484490102 | K083082 | 000 |
| 15060484490096 | K083082 | 000 |
| 15060484490003 | K083082 | 000 |
| 15060484490164 | K083082 | 000 |