510(k) K032755

MODEL 509M PULSE OXIMETER, MODEL 509M by Respironics Novametrix, Inc. — Product Code DQA

K032755 is an FDA 510(k) premarket notification submitted by Respironics Novametrix, Inc. for the device "MODEL 509M PULSE OXIMETER, MODEL 509M". The FDA issued a decision of Substantially Equivalent on May 21, 2004. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Respironics Novametrix, Inc. has at least 10 other 510(k) clearances on record.