MEDIKEEPER— 510(k) K912346
Substantially EquivalentMedikeeper, Inc.
FDA 510(k) clearance K912346 for MEDIKEEPER, Substantially Equivalent on 1991-07-30. Applicant: Medikeeper, Inc..
Clearance details
- Applicant
- Medikeeper, Inc.
- Product code
- Code BRY
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Philadelphia, PA, US
Adverse events under product code BRY
product code BRY- Death
- 9
- Malfunction
- 75,890
- Total
- 75,899
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.