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510(k) K122943

MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER by Moor Instruments, Ltd. — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2013
Date Received
September 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

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  • K032841 — MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR (December 10, 2003)
  • K011070 — DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR (November 7, 2001)

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