The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Airox Axr. 1a.
| Device ID | K901953 |
| 510k Number | K901953 |
| Device Name: | AIROX AXR. 1A |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-01 |
| Decision Date | 1991-01-02 |