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510(k) K102715

REGIONAL OXIMETER by Nonin Medical, Inc. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2010
Date Received
September 20, 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

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  • K160231 — Model X-100C CO-Met™ Oximetry System (December 23, 2016)
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  • K151305 — SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmar (August 27, 2015)
  • K140785 — PULSE OXIMETER (July 7, 2014)
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Other clearances for product code MUD

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  • K241393 — ODI-Tech (August 30, 2024)
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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)