510(k) K893867

CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE by Spacelabs, Inc. — Product Code DQA

K893867 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE". The FDA issued a decision of Substantially Equivalent on September 13, 1989. 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.