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510(k) K051257

ADULT CEREBRAL OXIMETER, MODEL 2040 by Cas Medical Systems, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2005
Date Received
May 16, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
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)

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