FDA 510(k)

Infinity Pro, Logic, Quality, Sprint

K-Number: K213742 · 2022-10-19

ApplicantOlsen Indústria E Comércio S.A.

Decision Date2022-10-19

Product CodeEIA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Infinity Pro, Logic, Quality, Sprint is a medical device manufactured by Olsen Indústria E Comércio S.A.. It received FDA 510(k) clearance on 2022-10-19 under approval number K213742. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infinity Pro, Logic, Quality, Sprint?

Infinity Pro, Logic, Quality, Sprint is a medical device that received FDA 510(k) clearance on 2022-10-19. It is manufactured by Olsen Indústria E Comércio S.A.. The 510(k) number is K213742.

When was Infinity Pro, Logic, Quality, Sprint approved by the FDA?

Infinity Pro, Logic, Quality, Sprint received FDA 510(k) clearance on 2022-10-19, under approval number K213742.

What company makes Infinity Pro, Logic, Quality, Sprint?

Infinity Pro, Logic, Quality, Sprint is manufactured by Olsen Indústria E Comércio S.A..

What is the FDA product code for Infinity Pro, Logic, Quality, Sprint?

The FDA product code for Infinity Pro, Logic, Quality, Sprint is EIA.

Related Devices (Code: EIA)

K161734Vanguard Dental UnitRitter Concept GmbH K161488ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH K151996TAURUS C1Shinhung Company, Ltd. K152100Evogue Dental UnitTakara Belmont Corporation K152830K3Osstem Implant Co., Ltd. K173608Forest Dental UnitForest Dental Products, Inc.

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.