Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K160981
Device Name Patient Monitor
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 Ave.
Suite 200
Sunnyvale,  CA  94089
Correspondent Contact DOUG WORTH
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZK   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DRG   DRT  
DSB   DSI   DSK   DXN   FLL   MLD  
NHO   NHP   NHQ  
Date Received04/07/2016
Decision Date 12/22/2016
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
Recalls CDRH Recalls
-
-