510(k) K060576

NELLCOR OXIMAX N-600X PULSE OXIMETER by Nellcor Puritan Bennett, Inc. — Product Code DQA

K060576 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "NELLCOR OXIMAX N-600X PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on August 14, 2006. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Nellcor Puritan Bennett, Inc. has at least 10 other 510(k) clearances on record.