The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Drt4 Laser Doppler Perfusion And Temperature Monitor.
| Device ID | K011070 |
| 510k Number | K011070 |
| Device Name: | DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-09 |
| Decision Date | 2001-11-07 |