SQuEEZ Software

System, Image Processing, Radiological

Cardiowise, Inc.

The following data is part of a premarket notification filed by Cardiowise, Inc. with the FDA for Squeez Software.

Pre-market Notification Details

Device IDK201250
510k NumberK201250
Device Name:SQuEEZ Software
ClassificationSystem, Image Processing, Radiological
Applicant Cardiowise, Inc. 535 W. Research Center Blvd., Suite 135 Fayetteville,  AR  72701
ContactJohn Coats
CorrespondentPierre Bounaud
AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego,  CA  92110
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-11
Decision Date2020-12-18

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