INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST— 510(k) K122480
Substantially EquivalentInternational Biophysics Corporation
FDA 510(k) clearance K122480 for INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST, Substantially Equivalent on 2013-03-27. Applicant: International Biophysics Corporation.
Clearance details
- Applicant
- International Biophysics Corporation
- Product code
- Code BYI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code BYI
product code BYI- Death
- 3
- Total
- 3
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.