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510(k) K940301

COMPEX 2 by Biodex Medical Systems, Inc. — Product Code IPF

Clearance Details

Decision
SN ()
Decision Date
December 28, 1994
Date Received
January 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Biodex Medical Systems, Inc.

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  • K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (November 16, 1995)
  • K950981 — ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 (April 3, 1995)
  • K942694 — STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 (March 10, 1995)
  • K935520 — UPPER BODY CYCLES (110 VOLT)/(220 VOLT) (September 16, 1994)
  • K935061 — LOWER BODY CYCLES (September 16, 1994)
  • K935216 — SEMI-RECUMBENT CYCLES (September 16, 1994)

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