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FDA 510(k)

NewTom 7G

K-Number: K220664 · 2022-05-06

ApplicantCefla S.C.
Decision Date2022-05-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NewTom 7G is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2022-05-06 under approval number K220664. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NewTom 7G?

NewTom 7G is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Cefla S.C.. The 510(k) number is K220664.

When was NewTom 7G approved by the FDA?

NewTom 7G received FDA 510(k) clearance on 2022-05-06, under approval number K220664.

What company makes NewTom 7G?

NewTom 7G is manufactured by Cefla S.C..

What is the FDA product code for NewTom 7G?

The FDA product code for NewTom 7G is JAK.

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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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