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FDA 510(k)

CipherOx CRI M1

K-Number: K173929 · 2018-07-24

ApplicantFlashback Technologies, Inc.
Decision Date2018-07-24
Product CodePPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CipherOx CRI M1 is a medical device manufactured by Flashback Technologies, Inc.. It received FDA 510(k) clearance on 2018-07-24 under approval 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. It is manufactured by Flashback Technologies, Inc.. The 510(k) number is K173929.

When was CipherOx CRI M1 approved by the FDA?

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

What company makes CipherOx CRI M1?

CipherOx CRI M1 is manufactured by Flashback Technologies, Inc..

What is the FDA product code for CipherOx CRI M1?

The FDA product code for CipherOx CRI M1 is PPW.

Other Devices by Flashback Technologies, Inc.

DEN160020CipherOx CRI Tablet K213255CipherOx CRI Tablet

Related Devices (Code: PPW)

DEN160020CipherOx CRI TabletFlashback Technologies, Inc. K213230T3 Platform SoftwareEtiometry, Inc. K213255CipherOx CRI TabletFlashback Technologies, Inc. K223578T3 Platform softwareEtiometry, Inc. K252204prolaio eVO2peak Module (Version 1.0)Prolaio, Inc. K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.

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.

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