MODEL 320 TWO CHANNEL AUDIOMETER— 510(k) K863984
Substantially EquivalentVirtual Corp.
FDA 510(k) clearance K863984 for MODEL 320 TWO CHANNEL AUDIOMETER, Substantially Equivalent on 1986-11-18. Applicant: Virtual Corp.. Device class: 2.
Clearance details
- Applicant
- Virtual Corp.
- 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
- Portland, OR, US
Recent devices under product code EWO
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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.