FDA 510(k) Application Details - K233280

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K233280
Device Name	Thermometer, Electronic, Clinical
Applicant	SteadySense GmbH Kaerntner Strasse 518 Seiersberg Pirka 8054 AT Other 510(k) Applications for this Company
Contact	Werner Koele 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	09/29/2023
Decision Date	06/21/2024
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