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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K192500
Device Name Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
Applicant
Honsun (Nantong) Co., Ltd.
#8, Tongxing Rd., Nantong Economic & Technology
Development Area
Nantong,  CN 226009
Applicant Contact Iris Du
Correspondent
Honsun (Nantong) Co., Ltd.
#8, Tongxing Rd., Nantong Economic & Technology
Development Area
Nantong,  CN 226009
Correspondent Contact Iris Du
Regulation Number870.1120
Classification Product Code
DXQ  
Subsequent Product Code
LDE  
Date Received09/12/2019
Decision Date 04/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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