DEN160020 is an FDA 510(k) submission for the CipherOx CRI Tablet. This device is classified as a Adjunctive Cardiovascular Status Indicator (Class II - Special Controls, product code PPW).
Submitted by Flashback Technologies, Inc. (Boulder, US). The FDA issued a Not Cleared (DENG) decision on December 21, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2200. The Adjunctive Cardiovascular Status Indicator Is A Prescription Device Based On Sensor Technology For The Measurement Of A Physical Parameter(s). This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy..
| 510(k) Number | DEN160020 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 24, 2016 |
| Decision Date | December 21, 2016 |
| Days to Decision | 211 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | PPW - Adjunctive Cardiovascular Status Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2200 |
| Definition | The Adjunctive Cardiovascular Status Indicator Is A Prescription Device Based On Sensor Technology For The Measurement Of A Physical Parameter(s). This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy. |