FDA 510(k) Application Details - K193213

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K193213
Device Name	Thermometer, Electronic, Clinical
Applicant	Kaz USA, Inc., a Helen of Troy Company 400 Donald Lynch Boulevard Suite 300 Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Matt J. Baun 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	11/21/2019
Decision Date	04/28/2020
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