X-MIND UNITY

Unit, X-ray, Extraoral With Timer

DE GOTZEN S.R.L.

The following data is part of a premarket notification filed by De Gotzen S.r.l. with the FDA for X-mind Unity.

Pre-market Notification Details

Device IDK132378
510k NumberK132378
Device Name:X-MIND UNITY
ClassificationUnit, X-ray, Extraoral With Timer
Applicant DE GOTZEN S.R.L. VIA ROMA 45 Olgiate Olona, Varese,  IT 21057
ContactMaurizio De Gotzen
CorrespondentMaurizio De Gotzen
DE GOTZEN S.R.L. VIA ROMA 45 Olgiate Olona, Varese,  IT 21057
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-31
Decision Date2014-05-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D804W08001520 K132378 000
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D804W08000000 K132378 000
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03760262650661 K132378 000
03760262650654 K132378 000
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D804W08000830 K132378 000
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D804W08001510 K132378 000
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D804W08000120 K132378 000
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D804W08000100 K132378 000
D804W08000090 K132378 000
D804W08001680 K132378 000

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