The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Ventilarm Ii Portable Airway Pressure Monitor.
| Device ID | K895747 |
| 510k Number | K895747 |
| Device Name: | VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| 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 | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-10-27 |