FDA 510(k) Application Details - K232516

Device Classification Name	Monitor, Carbon-Dioxide, Cutaneous   More FDA Info for this Device
510(K) Number	K232516
Device Name	Monitor, Carbon-Dioxide, Cutaneous
Applicant	Sentec AG Ringstrasse 39 Therwil 4106 CH Other 510(k) Applications for this Company
Contact	Caroline Moller Other 510(k) Applications for this Contact
Regulation Number	868.2480   More FDA Info for this Regulation Number
Classification Product Code	LKD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2023
Decision Date	05/17/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review