510(k) K912633

SALTER LABS INFANT MEDIUM CONCENTRATION MASK by Salter Labs — Product Code BYG

K912633 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "SALTER LABS INFANT MEDIUM CONCENTRATION MASK". The FDA issued a decision of Substantially Equivalent on July 19, 1991. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Salter Labs has at least 10 other 510(k) clearances on record.