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FDA 510(k)

OnePacs System

K-Number: K181460 · 2018-10-11

ApplicantOnepacs, LLC
Decision Date2018-10-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OnePacs System is a medical device manufactured by Onepacs, LLC. It received FDA 510(k) clearance on 2018-10-11 under approval number K181460. 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 OnePacs System?

OnePacs System is a medical device that received FDA 510(k) clearance on 2018-10-11. It is manufactured by Onepacs, LLC. The 510(k) number is K181460.

When was OnePacs System approved by the FDA?

OnePacs System received FDA 510(k) clearance on 2018-10-11, under approval number K181460.

What company makes OnePacs System?

OnePacs System is manufactured by Onepacs, LLC.

What is the FDA product code for OnePacs System?

The FDA product code for OnePacs System 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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