The following data is part of a premarket notification filed by Chad Therapeutics, Inc. with the FDA for Chad Therapeutics Oxymatic Model 401.
Device ID | K000890 |
510k Number | K000890 |
Device Name: | CHAD THERAPEUTICS OXYMATIC MODEL 401 |
Classification | Conserver, Oxygen |
Applicant | CHAD THERAPEUTICS, INC. 21622 PLUMMER ST. Chatsworth, CA 91311 |
Contact | Oscar J Sanchez |
Correspondent | Oscar J Sanchez CHAD THERAPEUTICS, INC. 21622 PLUMMER ST. Chatsworth, CA 91311 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-20 |
Decision Date | 2000-06-16 |