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FDA 510(k)

MIS Solution

K-Number: K203835 · 2021-04-23

Decision Date2021-04-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MIS Solution is a medical device manufactured by Next Science, LLC. It received FDA 510(k) clearance on 2021-04-23 under approval number K203835. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIS Solution?

MIS Solution is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Next Science, LLC. The 510(k) number is K203835.

When was MIS Solution approved by the FDA?

MIS Solution received FDA 510(k) clearance on 2021-04-23, under approval number K203835.

What company makes MIS Solution?

MIS Solution is manufactured by Next Science, LLC.

What is the FDA product code for MIS Solution?

The FDA product code for MIS Solution is FRO. This falls under the Anesthesiology category.

Other Devices by Next Science, LLC

Related Devices (Code: FRO)

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.