CipherOx CRI Tablet

Adjunctive Cardiovascular Status Indicator

Flashback Technologies, Inc.

The following data is part of a premarket notification filed by Flashback Technologies, Inc. with the FDA for Cipherox Cri Tablet.

Pre-market Notification Details

Device IDK213255
510k NumberK213255
Device Name:CipherOx CRI Tablet
ClassificationAdjunctive Cardiovascular Status Indicator
Applicant Flashback Technologies, Inc. 208 Lenox Ave #307 Westfield,  NJ  07090
ContactJohn Jedziniak
CorrespondentPaul Dryden
ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg,  FL  33704
Product CodePPW  
CFR Regulation Number870.2200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-06-17

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