The following data is part of a premarket notification filed by Chad Therapeutics, Inc. with the FDA for Oxymizer-pendant.
| Device ID | K834588 |
| 510k Number | K834588 |
| Device Name: | OXYMIZER-PENDANT |
| 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 | 1983-12-29 |
| Decision Date | 1984-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814470020256 | K834588 | 000 |
| 10814470020119 | K834588 | 000 |