KSEA REVERSE VIDEO

Endoscopic Video Imaging System/component, Gastroenterology-urology

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Reverse Video.

Pre-market Notification Details

Device IDK952482
510k NumberK952482
Device Name:KSEA REVERSE VIDEO
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactMarika Anderson
CorrespondentMarika Anderson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-30
Decision Date1995-10-23

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