FDA 510(k) Application Details - DEN230082

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230082
Device Name	Stone Clear (SC-LP9-01)
Applicant	SonoMotion, Inc. 1600 W. Hillsdale Blvd Suite 105 San Mateo, CA 94402 US Other 510(k) Applications for this Company
Contact	Oren Levy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2023
Decision Date	10/30/2024
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review