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FDA 510(k) Application Details - K201032
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K201032
Device Name
Thermometer, Electronic, Clinical
Applicant
Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.
EL-209 Shil Mahape Road Electronic Zone MIDC,
TTC Industrial Area
Mahape, Navi Mumbai 400710 IN
Other 510(k) Applications for this Company
Contact
Ramshankar Ghosh
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
04/20/2020
Decision Date
10/29/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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