510(k) K951605

SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM by Spacelabs, Inc. — Product Code DSH

K951605 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 14, 1995. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Spacelabs, Inc. has at least 10 other 510(k) clearances on record.