FDA 510(k) Application Details - K241662

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K241662
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda 42132 SE Other 510(k) Applications for this Company
Contact	Lin Huldeberg Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2024
Decision Date	08/30/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review