510(k) K082951

IMMERSION HYDROBATH by Arjo Hospital Equipment AB — Product Code ILJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2009
Date Received
October 3, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Hydro-Massage
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type