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FDA 510(k) Application Details - K203636
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K203636
Device Name
Thermometer, Electronic, Clinical
Applicant
JKH USA, LLC
20505 Valley Blvd. Suite 108
Walnut, CA 91789 US
Other 510(k) Applications for this Company
Contact
Bill Quanqin Dai
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/14/2020
Decision Date
08/31/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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