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.
Clearance details
- Applicant
- Us Hyperbaric Network
- Product code
- Code CBF
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medley, FL, US
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.