Revitalair 430+— 510(k) K220290
Substantially EquivalentUs Hyperbaric Network
FDA 510(k) clearance K220290 for Revitalair 430+, Substantially Equivalent on 2023-05-04. Applicant: Us Hyperbaric Network. Device class: 2.
Clearance details
- Applicant
- Us Hyperbaric Network
- Product code
- Code CBF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5470
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medley, FL, US
Recent devices under product code CBF
view all- K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
- K171899 — Revitalair 430F
- K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber Family
- K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
- K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
Adverse events under product code CBF
product code CBF- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.