FDA 510(k)

OnSite-IV

K-Number: K161800 · 2016-12-06

Decision Date2016-12-06

Product CodeLHI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

OnSite-IV is the device name listed in this FDA 510(k) record. The listed applicant is Pharmc, LLC. It received FDA 510(k) clearance on 2016-12-06 under 510(k) number K161800. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OnSite-IV?

OnSite-IV is a medical device that received FDA 510(k) clearance on 2016-12-06. The listed applicant is Pharmc, LLC. The 510(k) number is K161800.

When did OnSite-IV receive FDA 510(k) clearance?

OnSite-IV received FDA 510(k) clearance on 2016-12-06, under 510(k) number K161800.

Who is the listed applicant for OnSite-IV?

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

What is the FDA product code for OnSite-IV?

The FDA product code for OnSite-IV is LHI.

Related Devices (Code: LHI)

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.