FDA 510(k) Application Details - K163223

Device Classification Name	Chamber, Patient Isolation   More FDA Info for this Device
510(K) Number	K163223
Device Name	Chamber, Patient Isolation
Applicant	ISOVAC PRODUCTS, LLC 1306 ENTERPRISE DRIVE, UNIT C ROMEOVILLE, IL 60446 US Other 510(k) Applications for this Company
Contact	PETER M. JENKNER Other 510(k) Applications for this Contact
Regulation Number	880.5450   More FDA Info for this Regulation Number
Classification Product Code	LGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2016
Decision Date	11/02/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review