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510(k) K132163

MOORLDLS-BI LASER DOPPLER BURNS IMAGER by Moor Instruments, Ltd. — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2014
Date Received
July 12, 2013
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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  • K083082 — MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS (January 13, 2009)
  • K060976 — MOORLD12-B1 LASER DOPPLER BURNS IMAGER (March 27, 2007)
  • K063586 — MOORFLPI FULL-FIELD LASER PERFUSION IMAGER (January 25, 2007)
  • K063561 — MOORLDLS LASER DOPPLER LINE SCANNER (January 19, 2007)
  • 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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