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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K180380
Device Name vital signs monitor
Applicant
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District,
Pingshan District,
Shenzhen,  CN 518122
Applicant Contact Alice Yang
Correspondent
Edan Medical
1200 Crossman Ave.
Suite 200
Sunnyvale,  CA  94089
Correspondent Contact Doug Worth
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
DXN   FLL  
Date Received02/12/2018
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
Recalls CDRH Recalls
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