K173929 is an FDA 510(k) clearance for the CipherOx CRI M1. This device is classified as a Adjunctive Cardiovascular Status Indicator (Class II - Special Controls, product code PPW).
Submitted by Flashback Technologies, Inc. (Louisville, US). The FDA issued a Cleared decision on July 24, 2018, 210 days after receiving the submission on December 26, 2017.
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 | K173929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2017 |
| Decision Date | July 24, 2018 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| 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. |