CipherOx CRI M1— 510(k) K173929

Substantially Equivalent

Flashback Technologies, Inc.

FDA 510(k) clearance K173929 for CipherOx CRI M1, Substantially Equivalent on 2018-07-24. Applicant: Flashback Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Flashback Technologies, Inc.
Product code: Code PPW
Device class: Class 2
Regulation: 21 CFR 870.2200
Advisory panel: Cardiovascular
Date received: 2017-12-26
Decision date: 2018-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.