FDA device listing

RESPOND Ventilator

FDA device listing 1041468510 · CorVent Medical Inc.

Key facts

Proprietary names RESPOND Ventilator
Owner/operator CorVent Medical Inc.
Owner/operator number 10092028
Premarket submissions K241135
Product codes CBK
Device names CBK - Ventilator, Continuous, Facility Use
Device class Class II
Classification regulations (21 CFR) 868.5895
Review panels Anesthesiology
Registered establishments CORVENT MEDICAL INC.
Establishment registrations 3033571078
FEI numbers 3033571078
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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