ENT EM— 510(k) K223734
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K223734 for ENT EM, Substantially Equivalent on 2023-04-27. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Applicant
- Brainlab AG
- 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
- Traditional
- Location
- Munich, DE
Recent devices under product code PGW
view allMore clearances from Brainlab AG
view allAdverse 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.