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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, stationary
510(k) Number K201373
Device Name DRX-Compass
Applicant
Carestream Health, Inc
Building 7, No. 1510 Chuanqiao Road
china (shanghai) pilot free trade zone,  CN 201206
Applicant Contact duane gutowski
Correspondent
Carestream Health, Inc
Building 7, No. 1510 Chuanqiao Road
china (shanghai) pilot free trade zone,  CN 201206
Correspondent Contact duane gutowski
Regulation Number892.1680
Classification Product Code
KPR  
Date Received05/26/2020
Decision Date 06/26/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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