510(k) K864279

SPACELABS MODEL 90419 PULSE OXIMETER MODULE by Spacelabs, Inc. — Product Code DQA

K864279 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "SPACELABS MODEL 90419 PULSE OXIMETER MODULE". The FDA issued a decision of Substantially Equivalent on March 11, 1987. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Spacelabs, Inc. has at least 10 other 510(k) clearances on record.