OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4— 510(k) K020507
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K020507 for OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4, Substantially Equivalent on 2002-10-08. Applicant: Olympus Winter & Ibe GmbH.
Clearance details
- Applicant
- Olympus Winter & Ibe GmbH
- Product code
- Code GWG
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
Adverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
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.