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FDA 510(k)

Hakon, Hakon Smart

K-Number: K231901 · 2023-09-28

ApplicantMedical San Indústria DE Equipamentos Médicos Ltda.
Decision Date2023-09-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Hakon, Hakon Smart is the device name listed in this FDA 510(k) record. The listed applicant is Medical San Indústria DE Equipamentos Médicos Ltda.. It received FDA 510(k) clearance on 2023-09-28 under 510(k) number K231901. 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 Hakon, Hakon Smart?

Hakon, Hakon Smart is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Medical San Indústria DE Equipamentos Médicos Ltda.. The 510(k) number is K231901.

When did Hakon, Hakon Smart receive FDA 510(k) clearance?

Hakon, Hakon Smart received FDA 510(k) clearance on 2023-09-28, under 510(k) number K231901.

Who is the listed applicant for Hakon, Hakon Smart?

The FDA 510(k) record lists Medical San Indústria DE Equipamentos Médicos Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hakon, Hakon Smart?

The FDA product code for Hakon, Hakon Smart is GEX. This falls under the Gastroenterology category.

Other records listing Medical San Indústria DE Equipamentos Médicos Ltda. 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.

K241771Liftendo; Liftendo 2.0

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Official Source

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