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XYZ SYSTEM

by Bio-Monitoring International Corp.

510(k) K983550

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 NumberK983550 Date7 Jan 1999ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
HCC
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The XYZ SYSTEM is a biofeedback device classified under device class 2. It is designed for use in neurology applications, providing monitoring and feedback capabilities for neurological conditions.

The XYZ SYSTEM is supplied by Bio-Monitoring International Corp. and has received FDA 510(k) clearance with the K number K983550. It is a reusable device that is not specified as MRI safe. The device is authorized for use in clinical settings and is regulated under product code HCC.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the XYZ SYSTEM used for?

    The XYZ SYSTEM is a biofeedback device designed for neurology applications, providing monitoring and feedback capabilities for neurological conditions in clinical settings.

  • Is the XYZ SYSTEM reusable or single-use?

    The XYZ SYSTEM is a reusable device, meaning it can be used multiple times after proper cleaning and sterilization according to the manufacturer's instructions.

  • What regulatory approvals does the XYZ SYSTEM have?

    The XYZ SYSTEM has received FDA 510(k) clearance with K number K983550, making it substantially equivalent to other legally marketed devices in its class.

  • Is the XYZ SYSTEM MRI safe?

    The XYZ SYSTEM is not specified as MRI safe, so it should not be used in MRI environments unless specifically confirmed by the manufacturer.