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510(k) K091452

FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) by Cas Medical Systems, Inc. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2009
Date Received
May 18, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Tissue Saturation
Device Class
Class II
Regulation Number
870.2700
Review Panel
SU
Submission Type

Other clearances by Cas Medical Systems, Inc.

  • K190270 — FORE-SIGHT ELITE Tissue Oximeter Module (October 21, 2019)
  • K180003 — FORE-SIGHT ELITE Module Tissue Oximeter (May 10, 2018)
  • K150620 — 740 SELECT (May 8, 2015)
  • K143675 — FORE-SIGHT Elite Absolute Tissue Oximeter (April 10, 2015)
  • K140430 — 740 SELECT (June 13, 2014)
  • K133879 — FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (April 29, 2014)
  • K130411 — 740 SELECT (May 29, 2013)
  • K123700 — FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (April 11, 2013)
  • K112820 — FORE-SIGHT ABSOLUTE TISSUE OXIMETER (January 26, 2012)
  • K094030 — FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000 (December 23, 2010)

Other clearances for product code MUD

  • K243324 — Masimo O3 Regional Oximeter (July 17, 2025)
  • K250519 — Lap.Ox™ Laparoscopic Tissue Oximeter (June 26, 2025)
  • K240596 — Cerebral Autoregulation Index (CAI) Algorithm (October 16, 2024)
  • K241393 — ODI-Tech (August 30, 2024)
  • K240601 — SnapshotNIR model KD205 (April 2, 2024)
  • K232385 — OxiplexTS200 (March 1, 2024)
  • K233488 — Intra.Ox™ 2.0 Handheld Tissue Oximeter (February 28, 2024)
  • K230612 — Edwards Algorithm for Measurement of Blood Hemoglobin (November 17, 2023)
  • K223651 — Cerebral Adaptive Index (CAI) Algorithm (May 26, 2023)
  • K214072 — Masimo O3 Regional Oximeter System (May 6, 2022)