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510(k) K061191

FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 by Measurement Specialties, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2006
Date Received
April 28, 2006
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

Other clearances by Measurement Specialties, Inc.

  • K010706 — THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER (October 5, 2001)

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  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
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