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510(k) K943929

DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) by Greenleaf Medical Systems, Inc. — Product Code KQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
August 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Goniometer, Ac-Powered
Device Class
Class I
Regulation Number
888.1500
Review Panel
NE
Submission Type

Other clearances by Greenleaf Medical Systems, Inc.

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  • K893537 — GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM (October 10, 1989)
  • K884723 — (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM (February 8, 1989)

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  • K943898 — SAUNDERS ELECTRONIC INCLINOMETER (November 28, 1994)
  • K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
  • K925225 — THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (June 27, 1994)
  • K933063 — ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (January 27, 1994)