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FDA 510(k)

Adora DRFi (04550010)

K-Number: K242948 · 2024-12-23

ApplicantNrt X-Ray A/S
Decision Date2024-12-23
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Adora DRFi (04550010) is a medical device manufactured by Nrt X-Ray A/S. It received FDA 510(k) clearance on 2024-12-23 under approval number K242948. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Adora DRFi (04550010)?

Adora DRFi (04550010) is a medical device that received FDA 510(k) clearance on 2024-12-23. It is manufactured by Nrt X-Ray A/S. The 510(k) number is K242948.

When was Adora DRFi (04550010) approved by the FDA?

Adora DRFi (04550010) received FDA 510(k) clearance on 2024-12-23, under approval number K242948.

What company makes Adora DRFi (04550010)?

Adora DRFi (04550010) is manufactured by Nrt X-Ray A/S.

What is the FDA product code for Adora DRFi (04550010)?

The FDA product code for Adora DRFi (04550010) is JAA.

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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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