510(k) K913516

MODEL 520A NOVAMETRIX PULSE OXIMETER by Novametrix Medical Systems, Inc. — Product Code DQA

K913516 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "MODEL 520A NOVAMETRIX PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on November 4, 1991. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.