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FDA 510(k)

NFLK-2501 Portable X-ray Unit

K-Number: K211383 · 2021-08-13

ApplicantNeuf, Inc.
Decision Date2021-08-13
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NFLK-2501 Portable X-ray Unit is a medical device manufactured by Neuf, Inc.. It received FDA 510(k) clearance on 2021-08-13 under approval number K211383. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NFLK-2501 Portable X-ray Unit?

NFLK-2501 Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Neuf, Inc.. The 510(k) number is K211383.

When was NFLK-2501 Portable X-ray Unit approved by the FDA?

NFLK-2501 Portable X-ray Unit received FDA 510(k) clearance on 2021-08-13, under approval number K211383.

What company makes NFLK-2501 Portable X-ray Unit?

NFLK-2501 Portable X-ray Unit is manufactured by Neuf, Inc..

What is the FDA product code for NFLK-2501 Portable X-ray Unit?

The FDA product code for NFLK-2501 Portable X-ray Unit is IZL.

Other Devices by Neuf, Inc.

K230581TOPA12 Portable X-ray Unit

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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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