FDA device listing

Maxxi Snore Sensor

FDA device listing 1016891478 · NEUROVIRTUAL USA, INC.

Key facts

Proprietary names Maxxi Snore Sensor
Owner/operator NEUROVIRTUAL USA, INC.
Owner/operator number 9091724
Premarket submissions K191095
Product codes MNR
Device names MNR - Ventilatory Effort Recorder
Device class Class II
Classification regulations (21 CFR) 868.2375
Review panels Anesthesiology
Registered establishments NEUROVIRTUAL USA, INC.
Establishment registrations 3006125362
FEI numbers 3006125362
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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