510(k) K993637

N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS by Nellcor Puritan Bennett, Inc. — Product Code DQA

K993637 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS". The FDA issued a decision of Substantially Equivalent on November 24, 1999. 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.