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FDA 510(k)

OneMark

K-Number: K241762 · 2024-09-16

ApplicantView Point Medical
Decision Date2024-09-16
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OneMark is a medical device manufactured by View Point Medical. It received FDA 510(k) clearance on 2024-09-16 under approval number K241762. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OneMark?

OneMark is a medical device that received FDA 510(k) clearance on 2024-09-16. It is manufactured by View Point Medical. The 510(k) number is K241762.

When was OneMark approved by the FDA?

OneMark received FDA 510(k) clearance on 2024-09-16, under approval number K241762.

What company makes OneMark?

OneMark is manufactured by View Point Medical.

What is the FDA product code for OneMark?

The FDA product code for OneMark is NEU.

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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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