FDA 510(k) Application Details - K251071

Device Classification Name	More FDA Info for this Device
510(K) Number	K251071
Device Name	Fetal EchoScan (v1.1)
Applicant	BrightHeart 7-11 boulevard Haussmann Paris 75009 FR Other 510(k) Applications for this Company
Contact	Christophe Gardella Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2025
Decision Date	05/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review