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510(k) K964460

THE ROBOLITE by Shai Syg Motion and Innovations, Ltd. — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1997
Date Received
November 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
Review Panel
CH
Submission Type

Other clearances by Shai Syg Motion and Innovations, Ltd.

  • K961849 — THE ROBOGUIDE (August 21, 1996)

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