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510(k) K083598

KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION by KARL STORZ Endoscopy-America, Inc. — Product Code ODA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2009
Date Received
December 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Central Control Unit
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

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