FDA 510(k) Application Details - K142340

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K142340
Device Name Lamp, Infrared, Therapeutic Heating
Applicant Beijing Huatai Healthcare Technology Co., Ltd.
Rm.216, No.2 Building, No.18, Qinghe Anningzhuang East Road
Haidian District
Beijing 10085 CN
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Contact Bingxian Zheng
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 08/21/2014
Decision Date 12/02/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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