FDA 510(k)

CipherOx CRI M1

K-Number: K173929 · 2018-07-24

Decision Date2018-07-24

Product CodePPW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CipherOx CRI M1 is the device name listed in this FDA 510(k) record. The listed applicant is Flashback Technologies, Inc.. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K173929. The device is classified under product code PPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CipherOx CRI M1?

CipherOx CRI M1 is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Flashback Technologies, Inc.. The 510(k) number is K173929.

When did CipherOx CRI M1 receive FDA 510(k) clearance?

CipherOx CRI M1 received FDA 510(k) clearance on 2018-07-24, under 510(k) number K173929.

Who is the listed applicant for CipherOx CRI M1?

The FDA 510(k) record lists Flashback Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CipherOx CRI M1?

The FDA product code for CipherOx CRI M1 is PPW.

Other records listing Flashback Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213255CipherOx CRI Tablet

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.