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Sweden ♦ Miris HMA™ •미국 FDA -DEN180007•NICU.- 모유다량영양 진단 검사 측정기 - 최초 판매 승인

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Miris HMA™ Human Milk Analyser
미국 FDA : 모유 다량 영양 진단 검사 분석기 - 최초 NICU. 판매 승인

December 21, 2018

Miris AB
℅ John Smith,Partner
Hogan Lovells US LLP
555 Thirteenth Street
Washington, District of Columbia 20004

Re: DEN180007
Trade/Device Name: Miris Human Milk Analyzer
Regulation Number: 21 CFR 862.1493
Regulation Name: Breast milk macronutrients test system
Regulatory Class: Class II
Product Code: QEI
Dated: October 24, 2018
Received: October 24, 2018

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다운로드 DEN180007.pdf

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