Revitalair 430F— 510(k) K171899
Substantially EquivalentOxavita Srl
FDA 510(k) clearance K171899 for Revitalair 430F, Substantially Equivalent on 2019-11-22. Applicant: Oxavita Srl. Device class: 2.
Clearance details
- Applicant
- Oxavita Srl
- 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
- Buenos Aires, AR
Recent devices under product code CBF
view all- K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
- K220290 — Revitalair 430+
- 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.