Cleared Traditional

CipherOx CRI M1

K173929 · Flashback Technologies, Inc. · Cardiovascular
Jul 2018
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K173929 is an FDA 510(k) clearance for the CipherOx CRI M1, 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 review panel. Regulated under 21 CFR 870.2200.

Submission Details

510(k) Number K173929 FDA.gov
FDA Decision Cleared 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

Device Classification

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.