The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for 1160 Simple Isolation Valve & 1161 Filtered Valve.
| Device ID | K870138 |
| 510k Number | K870138 |
| Device Name: | 1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE |
| Classification | Valve, Non-rebreathing |
| 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 | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-13 |
| Decision Date | 1987-03-06 |