XPress BCD Breast Compression Device— 510(k) K163388

Name: FDA 510(k) clearance K163388
Creator: U.S. Food and Drug Administration
Published: 2017-07-19

Substantially Equivalent

Xpress Bcd, LLC

FDA 510(k) clearance K163388 for XPress BCD Breast Compression Device, Substantially Equivalent on 2017-07-19. Applicant: Xpress Bcd, LLC. Device class: 2.

Clearance details

Applicant: Xpress Bcd, LLC
Product code: Code POY
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2016-12-02
Decision date: 2017-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frederick, MD, US

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