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 |