Home / 510(k) Clearances / K950756

510(k) K950756

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1995
Date Received
February 17, 1995
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

Other clearances by Hill-Rom, Inc.

  • K202018 — Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom H (March 4, 2021)
  • K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different (May 7, 2018)
  • K143414 — Hill-Rom Wireless Connectivity Module (March 10, 2015)
  • K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
  • K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (September 19, 2011)
  • K013709 — HILL-ROM PRIMAVIEW MONITOR SYSTEM (November 16, 2001)
  • K973705 — CONTOR TABLE SURFACE (August 7, 1998)
  • K981081 — BRIGHTSTAR (April 29, 1998)
  • K972111 — RUMORS DYNAMIC AIR THERAPY UNIT (February 2, 1998)
  • K971366 — INCUWARMER (January 5, 1998)

Other clearances for product code IKZ

  • K972486 — PRESSUREGUARD IV (February 20, 1998)
  • K972111 — RUMORS DYNAMIC AIR THERAPY UNIT (February 2, 1998)
  • K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (April 30, 1997)
  • K954671 — THE FREEDOM BED (April 1, 1996)
  • 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)