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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K201032
Device Name Phoenix Digital Thermometer
Applicant
Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
El-209 Shil Mahape Rd. Electronic Zone Midc,
Ttc Industrial Area
Mahape, Navi Mumbai,  IN 400710
Applicant Contact Ramshankar Ghosh
Correspondent
Phoenix Healthcare Solutions, LLC
2281 Griffin Rd.
Fort Lauderdale,  FL  33312
Correspondent Contact Michael Stuart
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/20/2020
Decision Date 10/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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