510(k) K043004

STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 by Viasys Medsystems — Product Code FYA

K043004 is an FDA 510(k) premarket notification submitted by Viasys Medsystems for the device "STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031". The FDA issued a decision of Substantially Equivalent on March 16, 2005. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Viasys Medsystems has at least 6 other 510(k) clearances on record.