FDA 510(k) Application Details - K242487

Device Classification Name	Monitor, Ultrasonic, Nonfetal   More FDA Info for this Device
510(K) Number	K242487
Device Name	Monitor, Ultrasonic, Nonfetal
Applicant	Laminar Digital Health, Inc. 440 N Wolfe Road Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Jess Lee Other 510(k) Applications for this Contact
Regulation Number	892.1540   More FDA Info for this Regulation Number
Classification Product Code	JAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2024
Decision Date	12/13/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review