FDA 510(k) Application Details - K052798

Device Classification Name	Chamber, Patient Transport Isolation   More FDA Info for this Device
510(K) Number	K052798
Device Name	Chamber, Patient Transport Isolation
Applicant	ISOVAC PRODUCTS LLC 540 COLLEGE ST BELLAIRE, TX 77401 US Other 510(k) Applications for this Company
Contact	LISA S JONES Other 510(k) Applications for this Contact
Regulation Number	880.5450   More FDA Info for this Regulation Number
Classification Product Code	LGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2005
Decision Date	06/06/2006
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