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510(k) K102433

MOORVMS-PRES PRESSURE CUFF CONTROLLER by Moor Instruments, Ltd. — Product Code DPW

K102433 is an FDA 510(k) premarket notification submitted by Moor Instruments, Ltd. for the device "MOORVMS-PRES PRESSURE CUFF CONTROLLER". The FDA issued a decision of Substantially Equivalent on November 18, 2010. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Moor Instruments, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2010
Date Received
August 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Moor Instruments, Ltd.

  • K152749 — moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared (May 12, 2016)
  • K132163 — MOORLDLS-BI LASER DOPPLER BURNS IMAGER (January 29, 2014)
  • K122943 — MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (January 3, 2013)
  • K112826 — NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR (October 10, 2012)
  • 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)

Other clearances for product code DPW

  • K260700 — BlueDop Vascular Expert (July 8, 2026)
  • K252810 — FloPatch FP120 (April 24, 2026)
  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K251114 — FloPatch FP120 (June 20, 2025)
  • K243852 — Elfor-L (April 14, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K223843 — FloPatch FP120 (May 3, 2023)
  • K222242 — FloPatch FP120 (December 9, 2022)
  • K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2) (April 20, 2022)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)

FDA data resources