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 |