KARL STORZ DIRECT COUPLED CAMERA HEAD

Endoscopic Video Imaging System/component, Gastroenterology-urology

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 Camera Head.

Pre-market Notification Details

Device IDK973252
510k NumberK973252
Device Name:KARL STORZ DIRECT COUPLED CAMERA HEAD
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
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 CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-29
Decision Date1997-11-24
Summary:summary

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