510(k) K901209

MODEL 90489 PULSE OXIMETER MODULE by Spacelabs, Inc. — Product Code DQA

K901209 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "MODEL 90489 PULSE OXIMETER MODULE". The FDA issued a decision of Substantially Equivalent on April 30, 1990. 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.