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FDA 510(k)

LVIS NeuroMatch

K-Number: K222450 · 2023-06-09

ApplicantLVIS Corporation
Decision Date2023-06-09
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LVIS NeuroMatch is the device name listed in this FDA 510(k) record. The listed applicant is LVIS Corporation. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K222450. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LVIS NeuroMatch?

LVIS NeuroMatch is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is LVIS Corporation. The 510(k) number is K222450.

When did LVIS NeuroMatch receive FDA 510(k) clearance?

LVIS NeuroMatch received FDA 510(k) clearance on 2023-06-09, under 510(k) number K222450.

Who is the listed applicant for LVIS NeuroMatch?

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

What is the FDA product code for LVIS NeuroMatch?

The FDA product code for LVIS NeuroMatch is OMB.

Other records listing LVIS Corporation 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.

K250239NeuroMatchK241390NeuroMatch

Related Devices (Code: OMB)

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.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK243743autoSCORE (V 2.0.0)Holberg Eeg ASK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

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.

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