KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM

Neurological Stereotaxic Instrument

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 Karl Storz Navigationpanel Unit (npu) System.

Pre-market Notification Details

Device IDK122096
510k NumberK122096
Device Name:KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
ClassificationNeurological Stereotaxic Instrument
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo,  CA  90245
ContactLeigh Spotten
CorrespondentLeigh Spotten
KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo,  CA  90245
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-16
Decision Date2012-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551271087 K122096 000
04048551325292 K122096 000
04048551330319 K122096 000
04048551330326 K122096 000
04048551330401 K122096 000
04048551330456 K122096 000
04048551345139 K122096 000
04048551160992 K122096 000
04048551277577 K122096 000
04048551325988 K122096 000
04048551009888 K122096 000
04048551325285 K122096 000

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