The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Catalog No. 1755 1s0-neb, A Filtered Nebulizer.
| Device ID | K895231 |
| 510k Number | K895231 |
| Device Name: | CATALOG NO. 1755 1S0-NEB, A FILTERED 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 | 1989-08-22 |
| Decision Date | 1989-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704645859 | K895231 | 000 |
| 34026704642640 | K895231 | 000 |
| 24026704661460 | K895231 | 000 |
| 24026704670981 | K895231 | 000 |
| 24026704670837 | K895231 | 000 |
| 24026704595550 | K895231 | 000 |
| 24026704390520 | K895231 | 000 |