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Maxxi Snore Sensor

by Neurovirtual USA, Inc.

510(k) K191095

Maxxi Snore Sensor is a Class II device made by Neurovirtual USA, Inc., cleared under FDA 510(k) K191095 on 16 Jan 2020, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK191095 Date16 Jan 2020ClearedStatusActive

Official records

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  • Withdrawn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
MNR
Device class
Class II
Regulation
21 CFR Part 868.2375
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K191095

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K191095
UDI-DISize and differences
Neurovirtual Maxxi Snore 2ft Key connector
NEUROVIRTUAL USA, INC.
SI1866 / Maxxi Snore 2ft Key connector00850008393266
Single use: no
On the market
Neurovirtual Maxxi Snore 7ft Key connector
NEUROVIRTUAL USA, INC.
SI1784 / Maxxi Snore 7ft Key connector00850008393273
Single use: yes
On the market
Neurovirtual Maxxi Snore 7ft TP connector
NEUROVIRTUAL USA, INC.
SI1487 / Maxxi Snore 7ft TP connector00850008393280
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).

Other devices from Neurovirtual USA, Inc.

See all devices from Neurovirtual USA, Inc. →