OPTI 110/12/50 HSG

Assembly, Tube Housing, X-ray, Diagnostic

SIEMENS CORP.

The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Opti 110/12/50 Hsg.

Pre-market Notification Details

Device IDK781540
510k NumberK781540
Device Name:OPTI 110/12/50 HSG
ClassificationAssembly, Tube Housing, X-ray, Diagnostic
Applicant SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeITY  
CFR Regulation Number892.1760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-08
Decision Date1978-09-14

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