510(k) K970363

HYDROTEC LOW AIR LOSS THERAPY BED by Apex Metal, Inc. — Product Code IOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1997
Date Received
January 31, 1997
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