FDA 510(k) Application Details - K240220

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K240220
Device Name	Thermometer, Electronic, Clinical
Applicant	Taiwan Aulisa Medical Devices Technologies, Inc. 6F-2, No. 3-1, YuanQu St., Nangang Dist., Taipei City 115 TW Other 510(k) Applications for this Company
Contact	Jou An Hsu 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	01/26/2024
Decision Date	09/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review