FDA 510(k) Application Details - K190362

Device Classification Name	More FDA Info for this Device
510(K) Number	K190362
Device Name	HealthPNX
Applicant	Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Shefayim 6099000 IL Other 510(k) Applications for this Company
Contact	Flair Bar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2019
Decision Date	05/06/2019
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