FDA device listing

LSP AUTOVENT 3000

FDA device listing 1350329825 · Allied Medical LLC

Key facts

Proprietary names LSP AUTOVENT 3000
Owner/operator Allied Medical LLC
Owner/operator number 9919025
Premarket submissions K932199
Product codes BTL
Device names BTL - Ventilator, Emergency, Powered (Resuscitator)
Device class Class II
Classification regulations (21 CFR) 868.5925
Review panels Anesthesiology
Registered establishments Allied Medical LLC
Establishment registrations 1924066
FEI numbers 1924066
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 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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