510(k) K131099

AG MASS by Hospitech Respiration , Ltd. — Product Code JCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2013
Date Received
April 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type