The following data is part of a premarket notification filed by Chad Therapeutics, Inc. with the FDA for Chad Total O2 Delivery System.
| Device ID | K971889 |
| 510k Number | K971889 |
| Device Name: | CHAD TOTAL O2 DELIVERY SYSTEM |
| Classification | Generator, Oxygen, Portable |
| Applicant | CHAD THERAPEUTICS, INC. 21622 PLUMMER ST. Chatsworth, CA 91311 |
| Contact | Louie Goryoka |
| Correspondent | Louie Goryoka CHAD THERAPEUTICS, INC. 21622 PLUMMER ST. Chatsworth, CA 91311 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-21 |
| Decision Date | 1997-11-17 |