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510(k) K964873

SILKAIR LOW AIRLOSS THERAPY by Hill-Rom, Inc. — Product Code IOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1997
Date Received
December 5, 1996
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

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  • K973624 — NURSE'S AID PATIENT ROTATION SYSTEM (January 21, 1998)
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  • K951001 — FLEXICAIR EXLIPSE (June 27, 1995)
  • K945729 — DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE (February 27, 1995)