FDA 510(k) Application Details - K232462

Device Classification Name	System, Telethermographic (Adjunctive Use)   More FDA Info for this Device
510(K) Number	K232462
Device Name	System, Telethermographic (Adjunctive Use)
Applicant	USA Therm, Inc. 3100 Ray Ferrero Jr. Blvd, 5th Floor Fort Lauderdale, FL 33314 US Other 510(k) Applications for this Company
Contact	Eric Heil 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	08/15/2023
Decision Date	09/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review