KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM

Camera, Television, Endoscopic, Without Audio

KARL STORZ IMAGING, INC.

The following data is part of a premarket notification filed by Karl Storz Imaging, Inc. with the FDA for Karl Storz Direct Coupled Interface (dci 5) Camera System.

Pre-market Notification Details

Device IDK990154
510k NumberK990154
Device Name:KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
ClassificationCamera, Television, Endoscopic, Without Audio
Applicant KARL STORZ IMAGING, INC. 175 CREMONA DR. Goleta,  CA  93117
ContactTerry Fernandez
CorrespondentTerry Fernandez
KARL STORZ IMAGING, INC. 175 CREMONA DR. Goleta,  CA  93117
Product CodeFWF  
CFR Regulation Number878.4160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-19
Decision Date1999-06-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551064320 K990154 000
04048551064313 K990154 000

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