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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 K173036
Device Name North-vision Multi-parameter Patient Monitor
Applicant
North-Vision Tech., Inc.
1st Floor , #15, Gongye E.
2nd Rd., E. Dist.
Hsinchu City,  TW 30075
Applicant Contact Albert Huang
Correspondent
Pan-America Hyperbarics, Inc.
3528 Robin Rd.
Plano,  TX  75075
Correspondent Contact Shin-Ban Tsai
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/28/2017
Decision Date 12/21/2018
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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