INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER— 510(k) K981327
Substantially EquivalentIdem (Int'L Dist. of Electronics For Medicine)
FDA 510(k) clearance K981327 for INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER, Substantially Equivalent on 1998-05-11. Applicant: Idem (Int'L Dist. of Electronics For Medicine).
Clearance details
- Applicant
- Idem (Int'L Dist. of Electronics For Medicine)
- Product code
- Code EWO
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Benicia, CA, US
Adverse 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.