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510(k) K934689

LOW AIR LOSS MATTRESS, MODIFICATION by Cardio Systems, Inc. — Product Code INX

K934689 is an FDA 510(k) premarket notification submitted by Cardio Systems, Inc. for the device "LOW AIR LOSS MATTRESS, MODIFICATION". The FDA issued a decision of Substantially Equivalent on February 2, 1994. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160. Cardio Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1994
Date Received
August 23, 1993
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 Cardio Systems, Inc.

  • K131092 — STEALTH 360 ORBITAL PAD SYSTEM (June 24, 2013)
  • K081944 — MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (August 14, 2008)
  • K972022 — ZAK-2000 (January 22, 1998)
  • K921500 — CENTRI-SAFE(TM) VALVE (September 15, 1992)
  • K882177 — ADD-ON TO CRITICAL PATIENT CARE BED (December 1, 1988)
  • K852736 — BAYLOR RAPID AUTOTRANSFUSION SYSTEM (September 18, 1985)
  • K792152 — CARDIOPLEGIA SOLUTION ADMIN. SET (November 13, 1979)
  • K792151 — OXYGENATOR GAS LINE FILTER (November 13, 1979)

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)
  • 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