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FDA 510(k)

NEOSHIELD

K-Number: K172499 · 2018-06-01

Decision Date2018-06-01
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEOSHIELD is the device name listed in this FDA 510(k) record. The listed applicant is JMS North America Corporation. It received FDA 510(k) clearance on 2018-06-01 under 510(k) 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. The listed applicant is JMS North America Corporation. The 510(k) number is K172499.

When did NEOSHIELD receive FDA 510(k) clearance?

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

Who is the listed applicant for NEOSHIELD?

The FDA 510(k) record lists JMS North America Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEOSHIELD?

The FDA product code for NEOSHIELD is ONB.

Other records listing JMS North America Corporation as applicant

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.

Related Devices (Code: ONB)

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.

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.