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FDA 510(k)

Sapphire Infusion Pump, Sapphire administration sets

K-Number: K192860 · 2020-11-19

ApplicantQ Core Medical , Ltd.
Decision Date2020-11-19
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sapphire Infusion Pump, Sapphire administration sets is a medical device manufactured by Q Core Medical , Ltd.. It received FDA 510(k) clearance on 2020-11-19 under approval number K192860. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sapphire Infusion Pump, Sapphire administration sets?

Sapphire Infusion Pump, Sapphire administration sets is a medical device that received FDA 510(k) clearance on 2020-11-19. It is manufactured by Q Core Medical , Ltd.. The 510(k) number is K192860.

When was Sapphire Infusion Pump, Sapphire administration sets approved by the FDA?

Sapphire Infusion Pump, Sapphire administration sets received FDA 510(k) clearance on 2020-11-19, under approval number K192860.

What company makes Sapphire Infusion Pump, Sapphire administration sets?

Sapphire Infusion Pump, Sapphire administration sets is manufactured by Q Core Medical , Ltd..

What is the FDA product code for Sapphire Infusion Pump, Sapphire administration sets?

The FDA product code for Sapphire Infusion Pump, Sapphire administration sets is FRN.

Related Clinical Trials

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Other Devices by Q Core Medical , Ltd.

K161667Sapphire Infusion Pump

Related Devices (Code: FRN)

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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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