BAY AREA HYPERSCIENCES— 510(k) K030713
Substantially EquivalentBay Area Hypersciences, LLC
FDA 510(k) clearance K030713 for BAY AREA HYPERSCIENCES, Substantially Equivalent on 2003-12-19. Applicant: Bay Area Hypersciences, LLC.
Clearance details
- Applicant
- Bay Area Hypersciences, LLC
- Product code
- Code CBF
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Houston, TX, 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.