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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 the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) 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. The listed applicant is Cefla S.C.. The 510(k) number is K220664.

When did NewTom 7G receive FDA 510(k) clearance?

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

Who is the listed applicant for NewTom 7G?

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 7G?

The FDA product code for NewTom 7G is JAK.

Other records listing Cefla S.C. as applicant

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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Related Devices (Code: JAK)

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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