FDA 510(k) Application Details - DEN230008

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230008
Device Name	DermaSensor
Applicant	DermaSensor Inc. 80 SW 8th Street #2000 Miami, FL 33130 US Other 510(k) Applications for this Company
Contact	Cody Simmons Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2023
Decision Date	01/12/2024
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review