PointerShell Universal, PointerShell LS— 510(k) K160479
Substantially EquivalentFiagon GmbH
FDA 510(k) clearance K160479 for PointerShell Universal, PointerShell LS, Substantially Equivalent on 2016-03-23. Applicant: Fiagon GmbH. Device class: 2.
Clearance details
- Applicant
- Fiagon GmbH
- Product code
- Code PGW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hennigsdorf, DE
Recent devices under product code PGW
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Adverse events under product code PGW
product code PGW- Malfunction
- 1,199
- Total
- 1,199
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.