The following data is part of a premarket notification filed by Chad Therapeutics, Inc. with the FDA for Modification To Chad Therapeutics Oxymatic Model 401.
| Device ID | K003455 |
| 510k Number | K003455 |
| Device Name: | MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 |
| Classification | Conserver, Oxygen |
| Applicant | CHAD THERAPEUTICS, INC. 21622 PLUMMER ST. Chatsworth, CA 91311 |
| Contact | Kevin Mcculloh |
| Correspondent | Kevin Mcculloh CHAD THERAPEUTICS, INC. 21622 PLUMMER ST. Chatsworth, CA 91311 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-07 |
| Decision Date | 2000-12-06 |