510(k) K960251

COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR by Aristo Medical Products, Inc. — Product Code DQA

K960251 is an FDA 510(k) premarket notification submitted by Aristo Medical Products, Inc. for the device "COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR". The FDA issued a decision of Substantially Equivalent on March 26, 1996. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Aristo Medical Products, Inc. has at least 3 other 510(k) clearances on record.