Skip to content

Neurovirtual Maxxi Snore 2ft Key connector

by Neurovirtual USA, Inc.

Neurovirtual Maxxi Snore 2ft Key connector (SI1866) is a Class II device made by Neurovirtual USA, Inc., cleared under FDA 510(k) K191095 on 16 Jan 2020 and listed in FDA GUDID since 2 Apr 2020 (UDI-DI 00850008393266), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K191095

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850008393266 UDI-DI Date2 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191095 Date16 Jan 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191095 decided 16 Jan 2020 Active
  • FDA GUDID UDI-DI 00850008393266 listed 2 Apr 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191095
  2. Listed FDA GUDID 00850008393266

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neurovirtual
Generic name
Polysomnograph
Model / Ref / Catalog
Maxxi Snore 2ft Key connector, SI1866
Primary DI / UDI-DI
00850008393266
510(k) Number
FDA product code
MNR
GMDN term
Polysomnograph
Device class
Class II
Regulation number
868.2375
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Polysomnograph

Cleared under the same submission (K191095)

Similar devices in this category

Other devices filed under Polysomnograph.

Other devices from Neurovirtual USA, Inc.

See all devices from Neurovirtual USA, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)