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510(k) K944732

DEXTER ISOKINETIC by Cedaron Medical, Inc. — Product Code IKK

K944732 is an FDA 510(k) premarket notification submitted by Cedaron Medical, Inc. for the device "DEXTER ISOKINETIC". The FDA issued a decision of Substantially Equivalent on February 3, 1995. The device falls under product code IKK (System, Isokinetic Testing And Evaluation), a Class II device regulated under 21 CFR 890.1925.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1995
Date Received
August 25, 1994
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 for product code IKK

  • K123746 — AMES THERAPY DEVICE (May 24, 2013)
  • K952090 — HUMAC SYSTEM (December 11, 1995)
  • K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (November 16, 1995)
  • K951916 — CC RIDER, MODEL ME180 (October 4, 1995)
  • K950095 — CYBEX 770 (June 21, 1995)
  • K942229 — MOTIVATOR FTR 2000 (February 27, 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)
  • K922092 — SINGLE CHAIR INTEGRAL BACK ATTACHMENT (May 26, 1992)

FDA data resources