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FDA 510(k)

NewTom 5G XL

K-Number: K183448 · 2019-03-08

ApplicantCefla S.C.
Decision Date2019-03-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NewTom 5G XL is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2019-03-08 under 510(k) 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. The listed applicant is Cefla S.C.. The 510(k) number is K183448.

When did NewTom 5G XL receive FDA 510(k) clearance?

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

Who is the listed applicant for NewTom 5G XL?

The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for NewTom 5G XL is JAK.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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