FDA 510(k) Application Details - K231625

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K231625
Device Name	Thermometer, Electronic, Clinical
Applicant	Wellvii Inc 4521 PGA Blvd, PMB 341 Palm Beach Gardens, FL 33418 US Other 510(k) Applications for this Company
Contact	Mark Khachaturian 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	06/02/2023
Decision Date	02/02/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review