510(k) K000890

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

K000890 is an FDA 510(k) premarket notification submitted by Chad Therapeutics, Inc. for the device "CHAD THERAPEUTICS OXYMATIC MODEL 401". The FDA issued a decision of Substantially Equivalent on June 16, 2000. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2000
Date Received
March 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type