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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K061191
Device Name FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2
Applicant
MEASUREMENT SPECIALTIES, INC.
2300 MCDERMOTT ROAD
# 200-207
PLANO,  TX  75025
Applicant Contact KRISTA OAKES
Correspondent
MEASUREMENT SPECIALTIES, INC.
2300 MCDERMOTT ROAD
# 200-207
PLANO,  TX  75025
Correspondent Contact KRISTA OAKES
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received04/28/2006
Decision Date 05/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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