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510(k) K970636

TOTALCARE., MODULAR THERAPY SYSTEM (MTS) by Hill-Rom, Inc. — Product Code IOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
February 20, 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

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  • K973624 — NURSE'S AID PATIENT ROTATION SYSTEM (January 21, 1998)
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  • K964873 — SILKAIR LOW AIRLOSS THERAPY (July 3, 1997)
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  • K943433 — TOTAL CONTACT SEAT RIPPLE SYSTEM (July 31, 1995)
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