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SEM Scanner (Model 200)

DEN170021 Class I Direct
Decision Date
2018-12-20
Sponsor / Applicant
Bruin Biometrics, LLC

Technical Specification

510(k) Submission ID DEN170021
Product Code QEF
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.2100
Decision Date 2018-12-20
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

SEM Scanner (Model 200) received FDA 510(k) clearance under submission number DEN170021, sponsored by Bruin Biometrics, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2018-12-20.

Classification & Regulation

This clearance is catalogued under FDA product code QEF and 21 CFR 876.2100, within the Gastroenterology, Urology review panel as a Class I device.