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510(k) K100875

CEROX, MODEL 321OF by Or-Nim Medical , Ltd. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2011
Date Received
March 30, 2010
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 Or-Nim Medical , Ltd.

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  • K131854 — CEROX (September 13, 2013)
  • K093923 — CEROX MODEL 3210 (January 19, 2010)
  • K073407 — PACIFICA (February 28, 2008)

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  • 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)