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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K250231
Device Name Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)
Applicant
Dongguan E-Test Technology Co., Ltd.
Rm. 201,301, Bldg. 1, Changping Section #1,
Dongshen Rd., Changping Town
Dongguan,  CN 523570
Applicant Contact Wan Victor
Correspondent
Dongguan E-Test Technology Co., Ltd.
Rm. 201,301, Bldg. 1, Changping Section #1,
Dongshen Rd., Changping Town
Dongguan,  CN 523570
Correspondent Contact Wan Victor
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/27/2025
Decision Date 09/03/2025
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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