The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Moor Laser Blood Flow Monitor Mbf3.
| Device ID | K905232 |
| 510k Number | K905232 |
| Device Name: | MOOR LASER BLOOD FLOW MONITOR MBF3 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MOOR INSTRUMENTS LTD. MOORLAND RIDGE, TRINITY HILL Axminster, Devon, GB |
| Contact | N. J Barnett |
| Correspondent | N. J Barnett MOOR INSTRUMENTS LTD. MOORLAND RIDGE, TRINITY HILL Axminster, Devon, GB |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-01-11 |