ULTRA Telescopes— 510(k) K153009
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K153009 for ULTRA Telescopes, Substantially Equivalent on 2016-04-05. Applicant: Olympus Winter & Ibe GmbH.
Clearance details
- Applicant
- Olympus Winter & Ibe GmbH
- Product code
- Code EOB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamburg, DE
Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
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.