AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE

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 Hd Connect With Smartscreen / Blu-ray Drive / Smartscreen With Blu-ray Drive.

Pre-market Notification Details

Device IDK103308
510k NumberK103308
Device Name:AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE
ClassificationSystem, Image Processing, Radiological
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo,  CA  90245
ContactCrystal Dizol Hagan
CorrespondentCrystal Dizol Hagan
KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo,  CA  90245
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-09
Decision Date2011-08-29
Summary:summary

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