FDA 510(k) Application Details - K182572

Device Classification Name System, Image Processing, Radiological

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510(K) Number K182572
Device Name System, Image Processing, Radiological
Applicant Meddiff Technologies Pvt. Ltd.
Salarpuria Palladium, 3rd flor, #2021, 100 ft Road,
HAL 2ndStage
Bangalore 560 008 IN
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Contact Mr. Sanjeev
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/18/2018
Decision Date 04/12/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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