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 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.

Frequently Asked Questions

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.

Related Devices (Code: 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.