Cleared Traditional

CipherOx CRI Tablet

K213255 · Flashback Technologies, Inc. · Cardiovascular
Jun 2022
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K213255 is an FDA 510(k) clearance for the CipherOx CRI Tablet, a Adjunctive Cardiovascular Status Indicator (Class II — Special Controls, product code PPW), submitted by Flashback Technologies, Inc. (Westfield, US). The FDA issued a Cleared decision on June 17, 2022, 260 days after receiving the submission on September 30, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2200.

Submission Details

510(k) Number K213255 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2021
Decision Date June 17, 2022
Days to Decision 260 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.