encevis

by Ait Austrian Institute of Technology GmbH Austria 510(k)

510(k) K171720 Product code OMB

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK171720	Date19 Apr 2018Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 10 Oct 2026)

Specification

510(k) · synced 10 Oct 2026

510(k) Number: K171720
FDA Product Code: OMB

Device Class: Class II
Regulation: 21 CFR Part 882.1400
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K171720 24 fields · synced 10 Oct 2026