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510(k) K090807

REGIONAL OXIMETER SYSTEM, MODEL 7600 by Nonin Medical, Inc. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2009
Date Received
March 25, 2009
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 Nonin Medical, Inc.

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  • K172625 — Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor (May 11, 2018)
  • K160231 — Model X-100C CO-Met™ Oximetry System (December 23, 2016)
  • K160865 — Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C (August 5, 2016)
  • K151305 — SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmar (August 27, 2015)
  • K140785 — PULSE OXIMETER (July 7, 2014)
  • K132402 — SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM (February 21, 2014)

Other clearances for product code MUD

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  • 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)