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). Device class: 2.
Clearance details
- Applicant
- Idem (Int'L Dist. of Electronics For Medicine)
- 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
- Benicia, CA, US
Recent devices under product code EWO
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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.