510(k) K834460

MODEL 1888 ALPHA COS/RESPIRATION CAR by Spacelabs, Inc. — Product Code LLK

K834460 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "MODEL 1888 ALPHA COS/RESPIRATION CAR". The FDA issued a decision of Substantially Equivalent on February 13, 1984. The device falls under product code LLK (Legging, Compression, Non-Inflatable), a Class II device regulated under 21 CFR 880.5780. Spacelabs, Inc. has at least 10 other 510(k) clearances on record.