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FDA 510(k) Application Details - K200999
Device Classification Name
System, Telethermographic (Adjunctive Use)
More FDA Info for this Device
510(K) Number
K200999
Device Name
System, Telethermographic (Adjunctive Use)
Applicant
Thermidas Americas, Inc.
7912 Sailboat Key Blvd., Suite 508
South Pasadena, FL 33707 US
Other 510(k) Applications for this Company
Contact
Karo Kujanpaa
Other 510(k) Applications for this Contact
Regulation Number
884.2980
More FDA Info for this Regulation Number
Classification Product Code
LHQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/16/2020
Decision Date
01/06/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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