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510(k) K240601

SnapshotNIR model KD205 by Kent Imaging, Inc. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2024
Date Received
March 4, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Kent Imaging, Inc.

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  • K201976 — SnapshotNIR (November 10, 2020)
  • K163070 — Kent Camera (May 5, 2017)
  • K113507 — KENT CAMERA (August 8, 2012)

Other clearances for product code MUD

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  • K250519 — Lap.Ox™ Laparoscopic Tissue Oximeter (June 26, 2025)
  • K240596 — Cerebral Autoregulation Index (CAI) Algorithm (October 16, 2024)
  • K241393 — ODI-Tech (August 30, 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)
  • K221010 — Intra.Ox 2.0 Handheld Tissue Oximeter (May 3, 2022)