FDA 510(k) Application Details - K243729

Device Classification Name	More FDA Info for this Device
510(K) Number	K243729
Device Name	Prismira
Applicant	Lumos Labs, Inc. 16 Maiden Lane Ste 600 San Francisco, CA 94108 US Other 510(k) Applications for this Company
Contact	Robert (Bob) Schafer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2024
Decision Date	06/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review