AIDA COMPACT II SYSTEM

System, Image Processing, Radiological

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 Aida Compact Ii System.

Pre-market Notification Details

Device IDK052159
510k NumberK052159
Device Name:AIDA COMPACT II SYSTEM
ClassificationSystem, Image Processing, Radiological
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactPaul Lee
CorrespondentPaul Lee
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-09
Decision Date2005-09-07

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