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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 K161056
Device Name Telemetry Transmitter
Applicant
Edan Instruments, Inc.
3/F-B, Nanshan Medical Equipments Park,
Nanhai Rd 1019#
Shenzhen,  CN 518067
Applicant Contact Queena Chen
Correspondent
Edan Medical
1200 Crossman Way, Suite 200
Sunnyvale,  CA  94089
Correspondent Contact Doug Worth
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   DPS   DQA   DRG   DRT  
DSI   GXY   MLD  
Date Received04/14/2016
Decision Date 02/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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