Device Classification Name |
probe, blood-flow, extravascular
|
510(k) Number |
K152749 |
Device Name |
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager |
Applicant |
Moor Instruments Ltd |
Millwey Rise |
Axminster,
GB
EX13 5HU
|
|
Applicant Contact |
Stewart Lillington |
Correspondent |
Moor Instruments Ltd |
Millwey Rise |
Axminster,
GB
EX13 5HU
|
|
Correspondent Contact |
Stewart Lillington |
Regulation Number | 870.2120
|
Classification Product Code |
|
Date Received | 09/23/2015 |
Decision Date | 05/12/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|