FDA 510(k) Application Details - DEN240031

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240031
Device Name	Prapela SVS hospital bassinet pad (model P01)
Applicant	Prapela, Inc. 2 Main ST STE 15-219 Biddeford, ME 04005 US Other 510(k) Applications for this Company
Contact	John Konsin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2024
Decision Date	04/04/2025
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