FDA 510(k)

NEOSHIELD

K-Number: K172499 · 2018-06-01

Decision Date2018-06-01

Product CodeONB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NEOSHIELD is a medical device manufactured by JMS North America Corporation. It received FDA 510(k) clearance on 2018-06-01 under approval number K172499. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOSHIELD?

NEOSHIELD is a medical device that received FDA 510(k) clearance on 2018-06-01. It is manufactured by JMS North America Corporation. The 510(k) number is K172499.

When was NEOSHIELD approved by the FDA?

NEOSHIELD received FDA 510(k) clearance on 2018-06-01, under approval number K172499.

What company makes NEOSHIELD?

NEOSHIELD is manufactured by JMS North America Corporation.

What is the FDA product code for NEOSHIELD?

The FDA product code for NEOSHIELD is ONB.

Other Devices by JMS North America Corporation

K251877JMS CAVEO A.V. Fistula Needle Set

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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.