510(k) K063490

SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 by Spacelabs Medical, Inc. — Product Code DQK

K063490 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810". The FDA issued a decision of Substantially Equivalent on March 15, 2007. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.