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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 the device name listed in this FDA 510(k) record. The listed applicant is Flashback Technologies, Inc.. It received FDA 510(k) clearance on 2022-06-17 under 510(k) 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. The listed applicant is Flashback Technologies, Inc.. The 510(k) number is K213255.

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

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

Who is the listed applicant for CipherOx CRI Tablet?

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 Tablet?

The FDA product code for CipherOx CRI Tablet 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.

K173929CipherOx CRI M1

Related Devices (Code: PPW)

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.

K254066Etiometry PlatformEtiometry, Inc.K252204prolaio eVO2peak Module (Version 1.0)Prolaio, Inc.K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.K223578T3 Platform softwareEtiometry, Inc.K213230T3 Platform SoftwareEtiometry, Inc.K173929CipherOx CRI M1Flashback Technologies, 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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