510(k) K950447

FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT by Vital Signs, Inc. — Product Code BYD

K950447 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.