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FDA 510(k)

OnSite-IV

K-Number: K161800 · 2016-12-06

ApplicantPharmc, LLC
Decision Date2016-12-06
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OnSite-IV is a medical device manufactured by Pharmc, LLC. It received FDA 510(k) clearance on 2016-12-06 under approval 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. It is manufactured by Pharmc, LLC. The 510(k) number is K161800.

When was OnSite-IV approved by the FDA?

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

What company makes OnSite-IV?

OnSite-IV is manufactured by Pharmc, LLC.

What is the FDA product code for OnSite-IV?

The FDA product code for OnSite-IV is LHI.

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Official Source

View on FDA Database →

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

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