FDA device listing

Revitalair 430F

FDA device listing 1767326836 · Oxavita S.R.L.

Key facts

Proprietary names Revitalair 430F
Owner/operator Oxavita S.R.L.
Owner/operator number 10062498
Product codes CBF
Device names CBF - Chamber, Hyperbaric
Device class Class II
Classification regulations (21 CFR) 868.5470
Review panels Anesthesiology
Registered establishments OXAVITA S.R.L.
Establishment registrations 3016489995
FEI numbers 3016489995
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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