510(k) K951047

BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA by Vital Signs, Inc. — Product Code CAH

K951047 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA". The FDA issued a decision of Substantially Equivalent on June 2, 1995. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.