The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Moorldi Infrared Laser Doppler Imager, Model Moorld12-ir.
Device ID | K032841 |
510k Number | K032841 |
Device Name: | MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR |
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 | 2003-09-11 |
Decision Date | 2003-12-10 |
Summary: | summary |