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510(k) K221010

Intra.Ox 2.0 Handheld Tissue Oximeter by Vioptix, Inc. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2022
Date Received
April 5, 2022
Clearance Type
Special
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)
  • 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)
  • K042657 — VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 (January 10, 2005)

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)