AUDIOSCAN— 510(k) K926336
Substantially EquivalentElectrocaine Medical System
FDA 510(k) clearance K926336 for AUDIOSCAN, Substantially Equivalent on 1993-03-04. Applicant: Electrocaine Medical System. Device class: 2.
Clearance details
- Applicant
- Electrocaine Medical System
- Product code
- Code EWO
- Device class
- Class 2
- Regulation
- 21 CFR 874.1050
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lancaster, PA, US
Recent devices under product code EWO
view allMore clearances from Electrocaine Medical System
view allAdverse events under product code EWO
product code EWO- Other
- 2
- Total
- 2
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.