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FDA 510(k)

Ablation-fit

K-Number: K222938 · 2023-09-12

ApplicantR.A.W. S.R.L
Decision Date2023-09-12
Product CodeQTZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ablation-fit is a medical device manufactured by R.A.W. S.R.L. It received FDA 510(k) clearance on 2023-09-12 under approval number K222938. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ablation-fit?

Ablation-fit is a medical device that received FDA 510(k) clearance on 2023-09-12. It is manufactured by R.A.W. S.R.L. The 510(k) number is K222938.

When was Ablation-fit approved by the FDA?

Ablation-fit received FDA 510(k) clearance on 2023-09-12, under approval number K222938.

What company makes Ablation-fit?

Ablation-fit is manufactured by R.A.W. S.R.L.

What is the FDA product code for Ablation-fit?

The FDA product code for Ablation-fit is QTZ.

Related Devices (Code: QTZ)

Official Source

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