InPen System App (MMT-8060 (iOS), MMT-8061 (Android))— 510(k) K242775
Substantially EquivalentMedtronic Minimed
FDA 510(k) clearance K242775 for InPen System App (MMT-8060 (iOS), MMT-8061 (Android)), Substantially Equivalent on 2024-11-12. Applicant: Medtronic Minimed.
Clearance details
- Applicant
- Medtronic Minimed
- Product code
- Code NDC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
Adverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
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.