FDA 510(k) Application Details - K240933

Device Classification Name	Hyperthermia Monitor   More FDA Info for this Device
510(K) Number	K240933
Device Name	Hyperthermia Monitor
Applicant	Global Healthcare SG Sdn. Bhd Lot 43824, Jln Tech Valley 2/1, Bandar Sri Sendayan Seremban Negeri Sembilan 71950 MY Other 510(k) Applications for this Company
Contact	Keng Liang Cheng Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	NZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2024
Decision Date	03/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review