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FDA 510(k)

CipherOx CRI Tablet

K-Number: K213255 · 2022-06-17

ApplicantFlashback Technologies, Inc.
Decision Date2022-06-17
Product CodePPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CipherOx CRI Tablet is a medical device manufactured by Flashback Technologies, Inc.. It received FDA 510(k) clearance on 2022-06-17 under approval number K213255. 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 Tablet?

CipherOx CRI Tablet is a medical device that received FDA 510(k) clearance on 2022-06-17. It is manufactured by Flashback Technologies, Inc.. The 510(k) number is K213255.

When was CipherOx CRI Tablet approved by the FDA?

CipherOx CRI Tablet received FDA 510(k) clearance on 2022-06-17, under approval number K213255.

What company makes CipherOx CRI Tablet?

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

What is the FDA product code for CipherOx CRI Tablet?

The FDA product code for CipherOx CRI Tablet is PPW.

Other Devices by Flashback Technologies, Inc.

DEN160020CipherOx CRI Tablet K173929CipherOx CRI M1

Related Devices (Code: PPW)

DEN160020CipherOx CRI TabletFlashback Technologies, Inc. K173929CipherOx CRI M1Flashback Technologies, Inc. K213230T3 Platform SoftwareEtiometry, 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

View on FDA Database →

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

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