510(k) K021090

OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER by Nellcor Puritan Bennett, Inc. — Product Code DQA

K021090 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on May 8, 2002. 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.