The following data is part of a premarket notification filed by Chad Therapeutics, Inc. with the FDA for Oxymizer Flow Restrictor.
| Device ID | K841901 |
| 510k Number | K841901 |
| Device Name: | OXYMIZER FLOW RESTRICTOR |
| Classification | Tubing, Pressure And Accessories |
| Applicant | CHAD THERAPEUTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BYX |
| CFR Regulation Number | 868.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-07 |
| Decision Date | 1984-07-23 |