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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 K202851
Device Name Spo2 Sensor
Applicant
Jkh USA, LLC
20505 Valley Blvd. Suite 108
Walnut,  CA  91789
Applicant Contact Bill Quanqin Dai
Correspondent
Jkh USA, LLC
14271 Jeffrey Rd.
#246
Irvine,  CA  92620
Correspondent Contact Bill Quanqin Dai
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DSA  
Date Received09/28/2020
Decision Date 11/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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