The following data is part of a premarket notification filed by Revolutionary Medical Devices, Inc. with the FDA for Superno2va Et Device.
| Device ID | K173147 |
| 510k Number | K173147 |
| Device Name: | SuperNO2VA Et Device |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Revolutionary Medical Devices, Inc. 4090 E. Bujia Primera Tucson, AZ 85718 |
| Contact | David M. Kane |
| Correspondent | Paul Dryden ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-06-20 |
| Summary: | summary |