FDA 510(k) Application Details - K212045

Device Classification Name	More FDA Info for this Device
510(K) Number	K212045
Device Name	SoftSpot
Applicant	PediaMetrix, Inc. 155 Gibbs Street, Suite 537 Rockville, MD 20850 US Other 510(k) Applications for this Company
Contact	Joshua D Levin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2021
Decision Date	09/28/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review