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FDA 510(k)

DEKA AGAIN PRO family

K-Number: K233090 · 2023-10-27

ApplicantEl.En S.P.A.
Decision Date2023-10-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKA AGAIN PRO family is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K233090. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKA AGAIN PRO family?

DEKA AGAIN PRO family is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is El.En S.P.A.. The 510(k) number is K233090.

When did DEKA AGAIN PRO family receive FDA 510(k) clearance?

DEKA AGAIN PRO family received FDA 510(k) clearance on 2023-10-27, under 510(k) number K233090.

Who is the listed applicant for DEKA AGAIN PRO family?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA AGAIN PRO family?

The FDA product code for DEKA AGAIN PRO family is GEX. This falls under the Gastroenterology category.

Other records listing El.En S.P.A. as applicant

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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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