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510(k) K942694

STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 by Biodex Medical Systems, Inc. — Product Code KHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1995
Date Received
June 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Platform, Force-Measuring
Device Class
Class I
Regulation Number
890.1575
Review Panel
PM
Submission Type

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Other clearances for product code KHX

  • K951771 — COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM (August 11, 1995)
  • K946229 — BALANCE MANAGER (August 4, 1995)
  • K930089 — SMS BALANCE PERFORMANCE MONITOR (June 8, 1993)
  • K921340 — FORCE MEASURING PLATFORM (May 26, 1992)
  • K901069 — COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM (March 16, 1990)
  • K893254 — DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER (January 2, 1990)
  • K883130 — BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 (October 24, 1988)
  • K883131 — BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000 (October 24, 1988)
  • K883129 — BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000 (October 24, 1988)
  • K883198 — BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM (October 24, 1988)