FDA 510(k) Application Details - K201977

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K201977
Device Name	Thermometer, Electronic, Clinical
Applicant	Blue Spark Technologies Inc. 806 Sharon Drive, Suite G Westlake, OH 44145 US Other 510(k) Applications for this Company
Contact	John Gannon 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	07/16/2020
Decision Date	12/03/2020
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