510(k) K981655

SPACELABS MEDICAL DISPOSABLE SP02 SENSOR by Spacelabs Medical, Inc. — Product Code DQA

K981655 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS MEDICAL DISPOSABLE SP02 SENSOR". The FDA issued a decision of Substantially Equivalent on December 3, 1999. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.