510(k) K921499

SEAL RING FOR NASAL CPAP by Devilbiss Health Care, Inc. — Product Code BYG

K921499 is an FDA 510(k) premarket notification submitted by Devilbiss Health Care, Inc. for the device "SEAL RING FOR NASAL CPAP". The FDA issued a decision of Substantially Equivalent on September 17, 1992. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Devilbiss Health Care, Inc. has at least 10 other 510(k) clearances on record.