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Teca/Medelec Mistral Photic Stimulator

by Teca, Inc.

510(k) K880593

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880593 Date6 Apr 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Teca/Medelec Mistral
510(k) Number
FDA Product Code
GWE
Device Class
Class II
Regulation
21 CFR Part 882.1890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Teca/Medelec Mistral is a Photic Stimulator, Evoked Response, designed to elicit and measure visual evoked potentials (VEPs) in clinical neurology. This device delivers controlled light stimuli to assess retinal and visual pathway function, aiding in the diagnosis of conditions affecting vision or neurological integrity.

Used primarily in neurology settings, the Mistral is a reusable, non-sterile device intended for professional use by trained clinicians. It operates under FDA 510(k) clearance (K880593) and adheres to regulatory classification as a Class II medical device (GWE product code). No MRI safety or sterility requirements are specified, and its operation relies on standard electrical and optical safety standards.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical setting is the Mistral Photic Stimulator primarily intended for, and how does it assist clinicians?

    The Teca/Medelec Mistral is designed for use in neurology settings, where it helps clinicians assess retinal and visual pathway function by eliciting and measuring visual evoked potentials (VEPs). This aids in diagnosing conditions affecting vision or neurological integrity, such as optic nerve disorders or other visual pathway abnormalities.

  • Is the Mistral Photic Stimulator reusable or single-use, and what are its sterility requirements?

    The Mistral is a reusable, non-sterile device intended exclusively for professional use by trained clinicians. Since it is not classified as sterile, it does not require sterile handling or packaging, but standard infection control protocols should be followed during reuse.

  • How is the regulatory status of the Mistral Photic Stimulator defined, and what does this mean for its use?

    The Mistral holds FDA 510(k) clearance (K880593) and is classified as a Class II medical device under the GWE product code. This means it has been determined to be substantially equivalent to a legally marketed device and is subject to general controls, with special controls specific to photic stimulators. Its use is governed by FDA regulations, including adherence to electrical and optical safety standards.

  • Does the Mistral Photic Stimulator have any special considerations for MRI environments?

    The device does not specify MRI safety requirements, meaning it may not be explicitly labeled as MRI-compatible or safe for use in MRI environments. Clinicians should verify compatibility with their specific MRI system before use to avoid interference or safety risks.