FDA 510(k) Application Details - K171292

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K171292
Device Name Gas-Machine, Anesthesia
Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Building, Keji 12th Road South ,
Hi-tech Industrial Park,
Shenzhen 518057 CN
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Contact Yanhong Bai
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 05/02/2017
Decision Date 01/12/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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