MOORFLPI FULL-FIELD LASER PERFUSION IMAGER

Probe, Blood-flow, Extravascular

MOOR INSTRUMENTS LTD.

The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Moorflpi Full-field Laser Perfusion Imager.

Pre-market Notification Details

Device IDK063586
510k NumberK063586
Device Name:MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
ClassificationProbe, Blood-flow, Extravascular
Applicant MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon,  GB Ex13 5hu
ContactXiabing Huang
CorrespondentXiabing Huang
MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon,  GB Ex13 5hu
Product CodeDPT  
CFR Regulation Number870.2120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-01
Decision Date2007-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15060484490034 K063586 000

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