Cleerly Labs V2.0

System, Image Processing, Radiological

Cleerly, Inc.

The following data is part of a premarket notification filed by Cleerly, Inc. with the FDA for Cleerly Labs V2.0.

Pre-market Notification Details

Device IDK202280
510k NumberK202280
Device Name:Cleerly Labs V2.0
ClassificationSystem, Image Processing, Radiological
Applicant Cleerly, Inc. 101 Greenwich St, Suite 11C New York,  NY  10006
ContactJames K. Min
CorrespondentJohn Smith
Hogan Lovells US LLP 555 Thirteenth Street, NW Washington,  DC  20004
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-11
Decision Date2020-10-02

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