REXTAR X

Unit, X-ray, Extraoral With Timer

META BIOMED, INC.

The following data is part of a premarket notification filed by Meta Biomed, Inc. with the FDA for Rextar X.

Pre-market Notification Details

Device IDK132041
510k NumberK132041
Device Name:REXTAR X
ClassificationUnit, X-ray, Extraoral With Timer
Applicant META BIOMED, INC. 2600 MULLINIX MILL ROAD Mt. Airy,  MD  21771
ContactBlix Winston
CorrespondentBlix Winston
META BIOMED, INC. 2600 MULLINIX MILL ROAD Mt. Airy,  MD  21771
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-02
Decision Date2013-07-31
Summary:summary

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