FDA 510(k) Application Details - K190949

Device Classification Name	More FDA Info for this Device
510(K) Number	K190949
Device Name	ScanX Barrier Envelopes
Applicant	Air Techniques Inc. 1295 Walt Whitman Road Melville, NY 11747 US Other 510(k) Applications for this Company
Contact	Samir Ghevariya Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2019
Decision Date	07/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review