FDA 510(k)

MRCP+ v1.0

Número K: K183133 · 2019-01-09

Data da decisão2019-01-09

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

MRCP+ v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum Diagnostics, Ltd.. It received FDA 510(k) clearance on 2019-01-09 under 510(k) number K183133. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MRCP+ v1.0?

MRCP+ v1.0 is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is Perspectum Diagnostics, Ltd.. The 510(k) number is K183133.

When did MRCP+ v1.0 receive FDA 510(k) clearance?

MRCP+ v1.0 received FDA 510(k) clearance on 2019-01-09, under 510(k) number K183133.

Who is the listed applicant for MRCP+ v1.0?

The FDA 510(k) record lists Perspectum Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRCP+ v1.0?

The FDA product code for MRCP+ v1.0 is LLZ.

Outros registros que listam Perspectum Diagnostics, Ltd. como candidato(a)

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Fonte oficial

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