510(k) K952316

NELLCOR SYMPHONY N-3000 PULSE OXIMETER by Nellcor, Inc. — Product Code DQA

K952316 is an FDA 510(k) premarket notification submitted by Nellcor, Inc. for the device "NELLCOR SYMPHONY N-3000 PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on August 17, 1995. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Nellcor, Inc. has at least 10 other 510(k) clearances on record.