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510(k) K042657

VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 by Vioptix, Inc. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2005
Date Received
September 28, 2004
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 Vioptix, Inc.

  • K250519 — Lap.Ox™ Laparoscopic Tissue Oximeter (June 26, 2025)
  • K233488 — Intra.Ox™ 2.0 Handheld Tissue Oximeter (February 28, 2024)
  • K221010 — Intra.Ox 2.0 Handheld Tissue Oximeter (May 3, 2022)
  • K191676 — Intra.Ox 2.0 Handheld Tissue Oximeter (September 16, 2019)
  • K163472 — Intra.Ox Handheld Tissue Oximeter (November 16, 2017)
  • K133983 — INTRA. OX HANDHELD TISSUE OXIMETER (September 12, 2014)
  • K141234 — ODISSEY TISSUE OXIMETER (July 1, 2014)
  • K090679 — VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM (April 17, 2009)

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)