INTRABEAM SYSTEM

System, Therapeutic, X-ray

CARL ZEISS SURGICAL GMBH

The following data is part of a premarket notification filed by Carl Zeiss Surgical Gmbh with the FDA for Intrabeam System.

Pre-market Notification Details

Device IDK051055
510k NumberK051055
Device Name:INTRABEAM SYSTEM
ClassificationSystem, Therapeutic, X-ray
Applicant CARL ZEISS SURGICAL GMBH 49 PLAIN STREET North Attleboro,  MA  02760
ContactRosina Robinson
CorrespondentRosina Robinson
CARL ZEISS SURGICAL GMBH 49 PLAIN STREET North Attleboro,  MA  02760
Product CodeJAD  
CFR Regulation Number892.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-26
Decision Date2005-05-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049539064028 K051055 000

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