FDA 510(k)

Encevis

K-Number: K211452 · 2021-12-02

ApplicantAustrian Institute of Technology GmbH

Decision Date2021-12-02

Product CodeOMB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Encevis is the device name listed in this FDA 510(k) record. The listed applicant is Austrian Institute of Technology GmbH. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K211452. 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 Encevis?

Encevis is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Austrian Institute of Technology GmbH. The 510(k) number is K211452.

When did Encevis receive FDA 510(k) clearance?

Encevis received FDA 510(k) clearance on 2021-12-02, under 510(k) number K211452.

Who is the listed applicant for Encevis?

The FDA 510(k) record lists Austrian Institute of Technology GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Encevis?

The FDA product code for Encevis is OMB.

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, LLC K243743autoSCORE (V 2.0.0)Holberg Eeg AS K241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

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.