The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Ventilator Pressure Alarm Model Vpa-100.
| Device ID | K854934 |
| 510k Number | K854934 |
| Device Name: | VENTILATOR PRESSURE ALARM MODEL VPA-100 |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Contact | Anthony V Beran |
| Correspondent | Anthony V Beran RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-10 |
| Decision Date | 1985-12-24 |