Home / 510(k) Clearances / K920112

510(k) K920112

CLINITRON C-II by Support Systems Intl. — Product Code INX

K920112 is an FDA 510(k) premarket notification submitted by Support Systems Intl. for the device "CLINITRON C-II". The FDA issued a decision of Substantially Equivalent on January 24, 1992. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160. Support Systems Intl. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1992
Date Received
January 10, 1992
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 Support Systems Intl.

  • K941610 — CLENSICAIR LOW AIRLOSS HYDROTHERAPY (February 10, 1995)
  • K940662 — I-5000 (June 15, 1994)
  • K922973 — RESTCUE CC (July 30, 1992)
  • K920382 — FLEXICAIR LOW AIRLOSS THERAPY UNIT (April 7, 1992)

Other clearances for product code INX

  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K964223 — CLINITRON RITE-HITE (May 28, 1997)
  • 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)
  • K913654 — SMITH AND DAVIS PRESSURE THERAPY SYSTEM (November 22, 1991)

FDA data resources