The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for C.p.a.p. Nasal Cannula.
Device ID | K871157 |
510k Number | K871157 |
Device Name: | C.P.A.P. NASAL CANNULA |
Classification | Ventilator, Non-continuous (respirator) |
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 | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-24 |
Decision Date | 1987-04-21 |