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FDA 510(k)

LIFESYS PACS

K-Number: K161341 · 2017-04-05

ApplicantLifetrack Medical Systems, Inc.
Decision Date2017-04-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LIFESYS PACS is a medical device manufactured by Lifetrack Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-04-05 under approval number K161341. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESYS PACS?

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

When was LIFESYS PACS approved by the FDA?

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

What company makes LIFESYS PACS?

LIFESYS PACS is manufactured by Lifetrack Medical Systems, Inc..

What is the FDA product code for LIFESYS PACS?

The FDA product code for LIFESYS PACS is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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