The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Nebulizer, Handheld (t Up-draft).
| Device ID | K760489 |
| 510k Number | K760489 |
| Device Name: | NEBULIZER, HANDHELD (T UP-DRAFT) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-20 |
| Decision Date | 1976-09-03 |