FDA 510(k) Application Details - K221738

Device Classification Name	More FDA Info for this Device
510(K) Number	K221738
Device Name	NS-HGlio
Applicant	Neosoma Inc. 44 Farmers Row Groton, MA 01450 US Other 510(k) Applications for this Company
Contact	Aly H Abayazeed Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2022
Decision Date	09/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review