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510(k) K972111

RUMORS DYNAMIC AIR THERAPY UNIT by Hill-Rom, Inc. — Product Code IKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1998
Date Received
June 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Patient Rotation, Powered
Device Class
Class II
Regulation Number
890.5225
Review Panel
PM
Submission Type

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Other clearances for product code IKZ

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  • K950756 — PULMONEX DYNAMIC AIR THERAPY UNIT (May 30, 1995)
  • K950681 — MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY (May 16, 1995)
  • K933964 — THE CRADLE (October 3, 1994)
  • K923710 — OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED (March 22, 1993)
  • K922473 — TURN EZ BED DEVICE (September 9, 1992)
  • K905390 — KUDO (POWERED ROTATION BED) (January 8, 1991)
  • K905113 — ROTO REST; TRAUMA AND INTENSIVE CARE BED (November 26, 1990)