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510(k) K882177

ADD-ON TO CRITICAL PATIENT CARE BED by Cardio Systems, Inc. — Product Code IOQ

K882177 is an FDA 510(k) premarket notification submitted by Cardio Systems, Inc. for the device "ADD-ON TO CRITICAL PATIENT CARE BED". The FDA issued a decision of Substantially Equivalent on December 1, 1988. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Cardio Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1988
Date Received
May 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Flotation Therapy, Powered
Device Class
Class II
Regulation Number
890.5170
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)
  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K921500 — CENTRI-SAFE(TM) VALVE (September 15, 1992)
  • 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 IOQ

  • K143414 — Hill-Rom Wireless Connectivity Module (March 10, 2015)
  • K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
  • K973624 — NURSE'S AID PATIENT ROTATION SYSTEM (January 21, 1998)
  • K970363 — HYDROTEC LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970364 — AIRTEC2 LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (August 26, 1997)
  • K964873 — SILKAIR LOW AIRLOSS THERAPY (July 3, 1997)
  • K970295 — FLEXICAIR EXLIPSE PLUS (May 16, 1997)
  • K943433 — TOTAL CONTACT SEAT RIPPLE SYSTEM (July 31, 1995)
  • K951001 — FLEXICAIR EXLIPSE (June 27, 1995)

FDA data resources