KARL STORZ AUTOCLAVABLE 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 Autoclavable Camera Head.

Pre-market Notification Details

Device IDK994090
510k NumberK994090
Device Name:KARL STORZ AUTOCLAVABLE 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 Received1999-12-03
Decision Date2000-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551062333 K994090 000

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