BRAINLAB STEROTATIC HEADRING— 510(k) K952390
Substantially EquivalentBrainlab Med. Computersysteme GmbH
FDA 510(k) clearance K952390 for BRAINLAB STEROTATIC HEADRING, Substantially Equivalent on 1996-02-02. Applicant: Brainlab Med. Computersysteme GmbH.
Clearance details
- Applicant
- Brainlab Med. Computersysteme GmbH
- Product code
- Code HAW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 85586 Poing/Munchen, DE
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
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.