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510(k) K913020

BIODEX SYSTEM 2,MODEL S2-S by Biodex Corp. — Product Code IKK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1991
Date Received
July 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Isokinetic Testing And Evaluation
Device Class
Class II
Regulation Number
890.1925
Review Panel
PM
Submission Type

Other clearances by Biodex Corp.

  • K915846 — BIODEX SYSTEM 2 AUTOPROGRAM (January 13, 1992)
  • K915648 — BIODEX SYSTEM 2 AUTOPROGRAM (January 9, 1992)
  • K913021 — BIODEX,MODEL B-2000 (October 3, 1991)
  • K900450 — BIODEX LIFT SIMULATOR (July 24, 1990)
  • K900741 — BIODEX BACK SYSTEM ATTACHMENT (February 26, 1990)
  • K860821 — BIODEX SYSTEM (April 18, 1986)

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  • K951916 — CC RIDER, MODEL ME180 (October 4, 1995)
  • K950095 — CYBEX 770 (June 21, 1995)
  • K942229 — MOTIVATOR FTR 2000 (February 27, 1995)
  • K944732 — DEXTER ISOKINETIC (February 3, 1995)
  • K924414 — THE BTE DYNAMIC LIFT (February 12, 1993)
  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)
  • K922772 — TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (July 13, 1992)