The following data is part of a premarket notification filed by Chad Therapeutics, Inc. with the FDA for Oxymatictm Electronic Oxgyen Conserver.
Device ID | K852650 |
510k Number | K852650 |
Device Name: | OXYMATICTM ELECTRONIC OXGYEN CONSERVER |
Classification | Conserver, Oxygen |
Applicant | CHAD THERAPEUTICS, INC. 6324 VARIEL AVE., SUITE 323 Woodland Hills, CA 91367 |
Contact | Charles R Adams |
Correspondent | Charles R Adams CHAD THERAPEUTICS, INC. 6324 VARIEL AVE., SUITE 323 Woodland Hills, CA 91367 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-21 |
Decision Date | 1985-08-13 |