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

FDA 510(k)

ALGO 7i

K-Number: K211147 · 2021-10-14

ApplicantPath Medical GmbH
Decision Date2021-10-14
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ALGO 7i is a medical device manufactured by Path Medical GmbH. It received FDA 510(k) clearance on 2021-10-14 under approval 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. It is manufactured by Path Medical GmbH. The 510(k) number is K211147.

When was ALGO 7i approved by the FDA?

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

What company makes ALGO 7i?

ALGO 7i is manufactured by Path Medical GmbH.

What is the FDA product code for ALGO 7i?

The FDA product code for ALGO 7i is GWJ.

Other Devices by Path Medical GmbH

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

Related Devices (Code: GWJ)

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

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.

↑