510(k) K940662

I-5000 by Support Systems Intl. — Product Code IOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1994
Date Received
February 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Flotation Therapy, Powered
Device Class
Class II
Regulation Number
890.5170
Review Panel
PM
Submission Type