FDA device listing

LuMon(TM) System

FDA device listing 1158693339 · PERCUSSIONAIRE CORP.

Key facts

Proprietary names LuMon(TM) System
Owner/operator PERCUSSIONAIRE CORP.
Owner/operator number 9029650
Product codes QEB
Device names QEB - Ventilatory Electrical Impedance Tomograph
Device class Class II
Classification regulations (21 CFR) 868.1505
Review panels Anesthesiology
Registered establishments PERCUSSIONAIRE CORP.
Establishment registrations 3029845
FEI numbers 1000524541
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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