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FDA 510(k)

XPress BCD Breast Compression Device

Número K: K163388 · 2017-07-19

RequerenteXpress Bcd, LLC
Data da decisão2017-07-19
Código do produtoPOY
Comité consultivoRA
DecisãoSubstantially Equivalent

Resumo do dispositivo

XPress BCD Breast Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Xpress Bcd, LLC. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K163388. The device is classified under product code POY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the XPress BCD Breast Compression Device?

XPress BCD Breast Compression Device is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Xpress Bcd, LLC. The 510(k) number is K163388.

When did XPress BCD Breast Compression Device receive FDA 510(k) clearance?

XPress BCD Breast Compression Device received FDA 510(k) clearance on 2017-07-19, under 510(k) number K163388.

Who is the listed applicant for XPress BCD Breast Compression Device?

The FDA 510(k) record lists Xpress Bcd, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XPress BCD Breast Compression Device?

The FDA product code for XPress BCD Breast Compression Device is POY.

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