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FDA 510(k)

DEKA HELIX

K-Number: K222221 · 2023-01-04

ApplicantEl.En Electronic Engineering Spa
Decision Date2023-01-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKA HELIX is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K222221. 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 HELIX?

DEKA HELIX is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K222221.

When did DEKA HELIX receive FDA 510(k) clearance?

DEKA HELIX received FDA 510(k) clearance on 2023-01-04, under 510(k) number K222221.

Who is the listed applicant for DEKA HELIX?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA HELIX?

The FDA product code for DEKA HELIX is GEX. This falls under the Gastroenterology category.

Other records listing El.En Electronic Engineering Spa 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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