FDA 510(k) Application Details - DEN220048

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220048
Device Name	Neoasis
Applicant	Invictus Medical, Inc. 16601 Blanco Road Suite 120 San Antonio, TX 78232 US Other 510(k) Applications for this Company
Contact	George Hutchinson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2022
Decision Date	06/16/2023
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review