510(k) K010389

CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 by Chad Therapeutics, Inc. — Product Code NFB

K010389 is an FDA 510(k) premarket notification submitted by Chad Therapeutics, Inc. for the device "CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411". The FDA issued a decision of Substantially Equivalent on March 23, 2001. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Chad Therapeutics, Inc. has at least 10 other 510(k) clearances on record.