The following data is part of a premarket notification filed by Revolutionary Medical Devices, Inc. with the FDA for Superno2va Device.
| Device ID | K163277 |
| 510k Number | K163277 |
| Device Name: | SuperNO2VA Device |
| Classification | Mask, Gas, Anesthetic |
| Applicant | Revolutionary Medical Devices, Inc. 4090 E. Bujia Primera Tucson, AZ 85718 |
| Contact | David M. Kane |
| Correspondent | Paul Dryden ProMedic, LLC 24301 Woodsage Dr. Bonita Springs, FL 34134 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-10-13 |
| Summary: | summary |