AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS— 510(k) K043219
Substantially EquivalentInteracoustics AS
FDA 510(k) clearance K043219 for AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS, Substantially Equivalent on 2005-02-04. Applicant: Interacoustics AS. Device class: 2.
Clearance details
- Applicant
- Interacoustics AS
- 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
- Minnesota, MN, 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.