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FDA 510(k)

AROMA GRAND

K-Number: K211637 · 2021-09-03

ApplicantDaeju Meditech Engineering Co., Ltd.
Decision Date2021-09-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AROMA GRAND is the device name listed in this FDA 510(k) record. The listed applicant is Daeju Meditech Engineering Co., Ltd.. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K211637. 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 AROMA GRAND?

AROMA GRAND is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Daeju Meditech Engineering Co., Ltd.. The 510(k) number is K211637.

When did AROMA GRAND receive FDA 510(k) clearance?

AROMA GRAND received FDA 510(k) clearance on 2021-09-03, under 510(k) number K211637.

Who is the listed applicant for AROMA GRAND?

The FDA 510(k) record lists Daeju Meditech Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AROMA GRAND?

The FDA product code for AROMA GRAND is GEX. This falls under the Gastroenterology category.

Other records listing Daeju Meditech Engineering Co., Ltd. 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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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