FDA 510(k) Application Details - K232261

Device Classification Name	Electrode, Pacemaker, Temporary   More FDA Info for this Device
510(K) Number	K232261
Device Name	Electrode, Pacemaker, Temporary
Applicant	Osypka AG Earl-H.-Wood Str. 1 Rheinfelden 79618 DE Other 510(k) Applications for this Company
Contact	Nicola Osypka Other 510(k) Applications for this Contact
Regulation Number	870.3680   More FDA Info for this Regulation Number
Classification Product Code	LDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2023
Decision Date	04/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review