FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
K Number: K152749
·
Decision May 12, 2016
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
47
Applicant Total
14
Review Days
232
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Basic Information
- Device Name
- moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
- K Number
- K152749
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Moor Instruments, Ltd.
- Date Received
- September 23, 2015
- Decision Date
- May 12, 2016
- Product Code
- DPT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | FDA class 2 | Cardiovascular |
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Other Clearances by Moor Instruments, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K132163 | MOORLDLS-BI LASER DOPPLER BURNS IMAGER | Jan 29, 2014 | Substantially Equivalent |
| K122943 | MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER | Jan 3, 2013 | Substantially Equivalent |
| K112826 | NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR | Oct 10, 2012 | Substantially Equivalent |
| K102433 | MOORVMS-PRES PRESSURE CUFF CONTROLLER | Nov 18, 2010 | Substantially Equivalent |
| K083082 | MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS | Jan 13, 2009 | Substantially Equivalent |
| K060976 | MOORLD12-B1 LASER DOPPLER BURNS IMAGER | Mar 27, 2007 | Substantially Equivalent |
| K063586 | MOORFLPI FULL-FIELD LASER PERFUSION IMAGER | Jan 25, 2007 | Substantially Equivalent |
| K063561 | MOORLDLS LASER DOPPLER LINE SCANNER | Jan 19, 2007 | Substantially Equivalent |
| K032841 | MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR | Dec 10, 2003 | Substantially Equivalent |
| K011070 | DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR | Nov 7, 2001 | Substantially Equivalent |