510(k) K871594

BIRTHING ROOM WARMER by Air-Shields, Inc. — Product Code FMT

K871594 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "BIRTHING ROOM WARMER". The FDA issued a decision of Substantially Equivalent on June 5, 1987. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Air-Shields, Inc. has at least 10 other 510(k) clearances on record.