510(k) K905288

ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES by Med-Tek Innovations, Inc. — Product Code BYG

K905288 is an FDA 510(k) premarket notification submitted by Med-Tek Innovations, Inc. for the device "ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES". The FDA issued a decision of Substantially Equivalent on April 9, 1991. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Med-Tek Innovations, Inc. has at least 2 other 510(k) clearances on record.