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510(k) K093853

SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES by Nonin Medical, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2010
Date Received
December 16, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

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  • K140785 — PULSE OXIMETER (July 7, 2014)
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  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
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