FDA 510(k)

LIFESYS PACS

Número K: K161341 · 2017-04-05

RequerenteLifetrack Medical Systems, Inc.

Data da decisão2017-04-05

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

LIFESYS PACS is the device name listed in this FDA 510(k) record. The listed applicant is Lifetrack Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K161341. 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 LIFESYS PACS?

LIFESYS PACS is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Lifetrack Medical Systems, Inc.. The 510(k) number is K161341.

When did LIFESYS PACS receive FDA 510(k) clearance?

LIFESYS PACS received FDA 510(k) clearance on 2017-04-05, under 510(k) number K161341.

Who is the listed applicant for LIFESYS PACS?

The FDA 510(k) record lists Lifetrack Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFESYS PACS?

The FDA product code for LIFESYS PACS is LLZ.

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