FDA 510(k)

OnePacs System

K-Number: K181460 · 2018-10-11

Decision Date2018-10-11

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OnePacs System is the device name listed in this FDA 510(k) record. The listed applicant is Onepacs, LLC. It received FDA 510(k) clearance on 2018-10-11 under 510(k) 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. The listed applicant is Onepacs, LLC. The 510(k) number is K181460.

When did OnePacs System receive FDA 510(k) clearance?

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

Who is the listed applicant for OnePacs System?

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

What is the FDA product code for OnePacs System?

The FDA product code for OnePacs System is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.