The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Peep Valve.
Device ID | K902062 |
510k Number | K902062 |
Device Name: | PEEP VALVE |
Classification | Attachment, Breathing, Positive End Expiratory Pressure |
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 | BYE |
CFR Regulation Number | 868.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-08 |
Decision Date | 1990-09-04 |