GIGANTOS 1012 MP

Generator, High-voltage, X-ray, Diagnostic

SIEMENS CORP.

The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Gigantos 1012 Mp.

Pre-market Notification Details

Device IDK792393
510k NumberK792393
Device Name:GIGANTOS 1012 MP
ClassificationGenerator, High-voltage, X-ray, Diagnostic
Applicant SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIZO  
CFR Regulation Number892.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-26
Decision Date1979-12-20

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