FDA 510(k)

ALGO 7i

K-Number: K211147 · 2021-10-14

Decision Date2021-10-14

Product CodeGWJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ALGO 7i is the device name listed in this FDA 510(k) record. The listed applicant is Path Medical GmbH. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K211147. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALGO 7i?

ALGO 7i is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Path Medical GmbH. The 510(k) number is K211147.

When did ALGO 7i receive FDA 510(k) clearance?

ALGO 7i received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211147.

Who is the listed applicant for ALGO 7i?

The FDA 510(k) record lists Path Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALGO 7i?

The FDA product code for ALGO 7i is GWJ.

Other records listing Path Medical GmbH 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.

K220139QScreen K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE

Related Devices (Code: GWJ)

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbH K193033GSI Audera ProGrason Stadler K163326SmartEPIntelligent Hearing Systems K162037Eclipse with VEMPInteracoustics A/S

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.