510(k) K914335

STRAP, HEAD, GAS MASK by Vital Signs, Inc. — Product Code BTK

K914335 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "STRAP, HEAD, GAS MASK". The FDA issued a decision of Substantially Equivalent on April 2, 1992. The device falls under product code BTK (Strap, Head, Gas Mask), a Class I device regulated under 21 CFR 868.5560. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.