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Neurovision Medical Motion Sensor

by Neurovision Medical Products, Inc.

510(k) K130570

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130570↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK130570 Date26 Dec 2013ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
BZQ
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Neurovision Medical Motion Sensor is a Monitor, Breathing Frequency, designed to detect and measure respiratory motion. It is classified as a Class II medical device under FDA regulation 868.2375 and is intended for use in anesthesiology settings to assist in patient monitoring by providing real-time feedback on breathing patterns.

This device is supplied as a reusable, non-sterile instrument and is intended for use in clinical environments where patient respiratory monitoring is required. It is regulated under the FDA’s 510(k) clearance process and the EU’s Medical Device Regulation (MDR). The sensor operates within the scope of its designated advisory committee (AN) and is not intended for MRI environments. No specific storage conditions are detailed beyond standard medical device handling.

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Questions

AI-generated answers, 18 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 Neurovision Medical Motion Sensor primarily designed for, and how does it assist in patient care?

    The Neurovision Medical Motion Sensor is designed specifically for anesthesiology settings. It detects and measures respiratory motion in real-time, providing clinicians with immediate feedback on a patient’s breathing patterns. This helps monitor patients during procedures where respiratory stability is critical, such as surgeries or sedation.

  • Is the Neurovision Medical Motion Sensor intended for single-use or reusable applications, and what are the implications for maintenance?

    The Neurovision Medical Motion Sensor is supplied as a reusable instrument, meaning it is not intended for single-use. Since it is non-sterile, it must be cleaned and maintained according to standard medical device reprocessing protocols to ensure accurate performance and prevent cross-contamination in clinical environments.

  • Are there any specific storage requirements for the Neurovision Medical Motion Sensor beyond general medical device handling?

    The manufacturer does not specify any special storage conditions beyond standard medical device handling. This means it should be stored in a clean, dry environment, protected from physical damage, and following general guidelines for reusable medical equipment to maintain functionality.

  • Can the Neurovision Medical Motion Sensor be used in environments with MRI equipment, and why?

    No, the Neurovision Medical Motion Sensor is explicitly not intended for use in MRI environments. This is likely due to potential electromagnetic interference or safety concerns related to the sensor’s operation near magnetic fields, which could compromise its accuracy or pose risks to patients.

  • How was the regulatory pathway for the Neurovision Medical Motion Sensor determined, and what does this mean for its approval status?

    The device was classified as substantially equivalent under the FDA’s 510(k) clearance process, with a decision code of SESE (Substantially Equivalent Substantial Equivalence). This means the manufacturer demonstrated that the device is as safe and effective as a legally marketed predicate device, confirming its regulatory approval status through the FDA’s 510(k) pathway. It is also compliant with the EU’s Medical Device Regulation (MDR).