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510(k) K964223

CLINITRON RITE-HITE by Hill-Rom, Inc. — Product Code INX

K964223 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "CLINITRON RITE-HITE". The FDA issued a decision of Substantially Equivalent on May 28, 1997. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1997
Date Received
October 23, 1996
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

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 INX

  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K943385 — CLINITRON ELEXIS (February 27, 1995)
  • K942184 — CLINITRON AT HOME AIR FLUIDED THERAPY (February 7, 1995)
  • K931168 — X-20 AIR SUPPORT BED (February 17, 1994)
  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K924973 — DYLNAMEDICS A.S.A.P. (October 15, 1993)
  • K926402 — COMFORT CARE LOW AIR LOSS THERAPY BED (March 24, 1993)
  • K924686 — REM-AIR (February 12, 1993)
  • K920112 — CLINITRON C-II (January 24, 1992)
  • K913654 — SMITH AND DAVIS PRESSURE THERAPY SYSTEM (November 22, 1991)

FDA data resources