Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Olsen Indústria E Comércio S.A.. It received FDA 510(k) clearance on 2022-10-19 under 510(k) 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. The listed applicant is Olsen Indústria E Comércio S.A.. The 510(k) number is K213742.

When did Infinity Pro, Logic, Quality, Sprint receive FDA 510(k) clearance?

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

Who is the listed applicant for Infinity Pro, Logic, Quality, Sprint?

The FDA 510(k) record lists Olsen Indústria E Comércio S.A. as the applicant. This does not by itself establish the device manufacturer.

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)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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.

↑