510(k) K881705

MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM by Surgi-Med, Inc. — Product Code INX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1988
Date Received
April 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Air Fluidized
Device Class
Class II
Regulation Number
890.5160
Review Panel
PM
Submission Type