510(k) K040485

MAXAIR SURGICAL HELMET SYSTEM by Bio-Medical Devices, Inc. — Product Code FYA

K040485 is an FDA 510(k) premarket notification submitted by Bio-Medical Devices, Inc. for the device "MAXAIR SURGICAL HELMET SYSTEM". The FDA issued a decision of Substantially Equivalent on October 18, 2004. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Bio-Medical Devices, Inc. has at least 6 other 510(k) clearances on record.