The following data is part of a premarket notification filed by Chad Therapeutics, Inc. with the FDA for Oxymizer.
Device ID | K830009 |
510k Number | K830009 |
Device Name: | OXYMIZER |
Classification | Conserver, Oxygen |
Applicant | CHAD THERAPEUTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-03 |
Decision Date | 1983-04-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10814470020126 | K830009 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OXYMIZER 73445657 1324305 Live/Registered |
Chad Therapeutics, Inc. 1983-09-28 |