FDA 510(k)

NewTom 5G XL

K-Number: K183448 · 2019-03-08

Decision Date2019-03-08

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NewTom 5G XL is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2019-03-08 under approval number K183448. 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 5G XL?

NewTom 5G XL is a medical device that received FDA 510(k) clearance on 2019-03-08. It is manufactured by Cefla S.C.. The 510(k) number is K183448.

When was NewTom 5G XL approved by the FDA?

NewTom 5G XL received FDA 510(k) clearance on 2019-03-08, under approval number K183448.

What company makes NewTom 5G XL?

NewTom 5G XL is manufactured by Cefla S.C..

What is the FDA product code for NewTom 5G XL?

The FDA product code for NewTom 5G XL 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.