FDA 510(k) Application Details - K241397

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K241397
Device Name	System,Network And Communication,Physiological Monitors
Applicant	Hinlab SAS 11 rue Alfred de Musset Neuilly sur Seine 92200 FR Other 510(k) Applications for this Company
Contact	Denys-Michel De LarouziΦre Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2024
Decision Date	11/14/2024
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