OLYMPUS NEURO ENDOSCOPE— 510(k) K971340
Substantially EquivalentOlympus Optical, Co.
FDA 510(k) clearance K971340 for OLYMPUS NEURO ENDOSCOPE, Substantially Equivalent on 1998-07-29. Applicant: Olympus Optical, Co.. Device class: 2.
Clearance details
- Applicant
- Olympus Optical, Co.
- Product code
- Code GWG
- Device class
- Class 2
- Regulation
- 21 CFR 882.1480
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck,, NY, US
Recent devices under product code GWG
view allMore clearances from Olympus Optical, Co.
view allAdverse 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.