510(k) K962848

HANS RUDOLPH NASAL CPAP MASK by Hans Rudolph, Inc. — Product Code BYG

K962848 is an FDA 510(k) premarket notification submitted by Hans Rudolph, Inc. for the device "HANS RUDOLPH NASAL CPAP MASK". The FDA issued a decision of Substantially Equivalent on October 16, 1996. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Hans Rudolph, Inc. has at least 10 other 510(k) clearances on record.