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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K253196
Device Name Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
Applicant
Midmark Corporation
60 Vista Dr.
Versailles,  OH  45380
Applicant Contact Jessica Hembrey
Correspondent
Midmark Corporation
60 Vista Dr.
Versailles,  OH  45380
Correspondent Contact Jessica Hembrey
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/26/2025
Decision Date 06/12/2026
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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