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FDA 510(k) Application Details - K152030
Device Classification Name
More FDA Info for this Device
510(K) Number
K152030
Device Name
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
Applicant
Qingdao Hisense Medical Equipment Co., Ltd.
Software Outsourcing center 3rd floor north wing
No. 169 Songling Road, Laoshan
Qing dao 266101 CN
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Contact
Liu Zhitang
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PGY
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More FDA Info for this Product Code
Date Received
07/22/2015
Decision Date
09/16/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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