The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Mooorldi Laser Doppler Imager.
| Device ID | K980383 |
| 510k Number | K980383 |
| Device Name: | MOOORLDI LASER DOPPLER 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 | 1998-02-02 |
| Decision Date | 1998-04-30 |
| Summary: | summary |