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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 K912588
Device Name AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS
Applicant
Sein Electronics Co., Ltd.
C/O The Lahr Consulting Group
One Lethbridge Plz., Suite 7
Mahwah,  NJ  07430
Applicant Contact BRENDA M KELLY
Correspondent
Sein Electronics Co., Ltd.
C/O The Lahr Consulting Group
One Lethbridge Plz., Suite 7
Mahwah,  NJ  07430
Correspondent Contact BRENDA M KELLY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/12/1991
Decision Date 12/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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