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

K061191 is an FDA 510(k) premarket notification submitted by Measurement Specialties, Inc. for the device "FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2". The FDA issued a decision of Substantially Equivalent on May 22, 2006. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Measurement Specialties, Inc. has at least 1 other 510(k) clearance on record.