FDA 510(k) Application Details - DEN170056

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170056
Device Name	Parathyroid Detection (Model PTeye) System
Applicant	AiBiomed, Corp. 107 West Gutierrez Sreet Santa Barbara, CA 93101 US Other 510(k) Applications for this Company
Contact	Al Memmolo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2017
Decision Date	11/02/2018
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