FDA 510(k) Application Details - K222311

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K222311
Device Name	Thermometer, Electronic, Clinical
Applicant	CIRCA Scientific, Inc. 14 Inverness Drive East, Suite H-136 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Fred Piazza 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	08/01/2022
Decision Date	05/25/2023
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