510(k) K772127

OXYGEN MASK, AIR-ENTRAINMENT by Salter Labs — Product Code BYF

K772127 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "OXYGEN MASK, AIR-ENTRAINMENT". The FDA issued a decision of Substantially Equivalent on January 3, 1978. The device falls under product code BYF (Mask, Oxygen, Low Concentration, Venturi), a Class I device regulated under 21 CFR 868.5600. Salter Labs has at least 10 other 510(k) clearances on record.