FDA 510(k) Application Details - K223049

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K223049
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Icentia Inc. 2750 Einstein St Quebec G1P4R1 CA Other 510(k) Applications for this Company
Contact	DaniΦle Grondines Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	DSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2022
Decision Date	03/22/2023
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