The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Mouth To Mask Emergency Ventilation.
| Device ID | K841429 |
| 510k Number | K841429 |
| Device Name: | MOUTH TO MASK EMERGENCY VENTILATION |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | O-TWO SYSTEMS INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-06 |
| Decision Date | 1984-04-17 |