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510(k) K943385

CLINITRON ELEXIS by Ssi Medical Services, Inc. — Product Code INX

K943385 is an FDA 510(k) premarket notification submitted by Ssi Medical Services, Inc. for the device "CLINITRON ELEXIS". The FDA issued a decision of Substantially Equivalent on February 27, 1995. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160. Ssi Medical Services, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1995
Date Received
July 13, 1994
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 Ssi Medical Services, Inc.

  • K942184 — CLINITRON AT HOME AIR FLUIDED THERAPY (February 7, 1995)
  • K914351 — CLINITRON C-10 (February 14, 1992)
  • K890523 — SUPERCAIR (February 10, 1989)
  • K882161 — ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM (July 12, 1988)
  • K863047 — FLEXICAIR (September 5, 1986)

Other clearances for product code INX

  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K964223 — CLINITRON RITE-HITE (May 28, 1997)
  • 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