510(k) K020475

CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 by Chad Therapeutics, Inc. — Product Code NFB

K020475 is an FDA 510(k) premarket notification submitted by Chad Therapeutics, Inc. for the device "CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511". The FDA issued a decision of Substantially Equivalent on July 5, 2002. 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
July 5, 2002
Date Received
February 12, 2002
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