FDA 510(k) Application Details - K193259

Device Classification Name Blood Pressure Cuff

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510(K) Number K193259
Device Name Blood Pressure Cuff
Applicant Little Doctor Electronic (Nantong)Co.,Ltd
No.14, Zhenxingxilu Road, Chongchuan Area
Nantong 226000 CN
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Contact Iris Du
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 11/26/2019
Decision Date 07/02/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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