The following data is part of a premarket notification filed by Chad Therapeutics, Inc. with the FDA for Oxymatic-24.
Device ID | K884562 |
510k Number | K884562 |
Device Name: | OXYMATIC-24 |
Classification | Conserver, Oxygen |
Applicant | CHAD THERAPEUTICS, INC. 21630 LASSEN ST. Chatsworth, CA 91311 |
Contact | Charles R Adams |
Correspondent | Charles R Adams CHAD THERAPEUTICS, INC. 21630 LASSEN 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 | 1988-10-31 |
Decision Date | 1989-01-09 |