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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(With Arrhythmia Detection Or Alarms)
510(k) Number K252250
Device Name Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)
Applicant
Shanghai Draeger Medical Instrument Co., Ltd.
# 229 Hupo Rd., Shanghai International Medical Zone
Pudong New Area
Shanghai,  CN 201321
Applicant Contact Xuguang Miao
Correspondent
Shanghai Draeger Medical Instrument Co., Ltd.
# 229 Hupo Rd., Shanghai International Medical Zone
Pudong New Area
Shanghai,  CN 201321
Correspondent Contact Xuguang Miao
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/17/2025
Decision Date 04/10/2026
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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