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510(k) K881705

MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM by Surgi-Med, Inc. — Product Code INX

K881705 is an FDA 510(k) premarket notification submitted by Surgi-Med, Inc. for the device "MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 13, 1988. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160. Surgi-Med, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1988
Date Received
April 19, 1988
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 Surgi-Med, Inc.

  • K873047 — KEANE MOBILITY BED (October 15, 1987)
  • K872923 — PARAGON 9000 TILT AND TURN BED (October 14, 1987)
  • K872924 — PARAGON 8500 CARDIO-PULMONARY BED (October 9, 1987)
  • K872925 — MEGABED 1000 (September 15, 1987)

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)
  • K920112 — CLINITRON C-II (January 24, 1992)

FDA data resources