The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for In-the Nebulizer.
| Device ID | K900470 |
| 510k Number | K900470 |
| Device Name: | IN-THE NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 27711 DIAZ ST. P.O. BOX 66 Temecula, CA 92390 |
| Contact | Jorge Haider |
| Correspondent | Jorge Haider HUDSON OXYGEN THERAPY SALES CO. 27711 DIAZ ST. P.O. BOX 66 Temecula, CA 92390 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-31 |
| Decision Date | 1990-05-18 |