The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Demand Oxygen Controller.
| Device ID | K833351 |
| 510k Number | K833351 |
| Device Name: | DEMAND OXYGEN CONTROLLER |
| Classification | Catheter, Nasal, Oxygen |
| Applicant | HEALTHDYNE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZB |
| CFR Regulation Number | 868.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-28 |
| Decision Date | 1984-03-19 |