AUDIOMETRIC TESTING SYS., SERIES 500— 510(k) K770823
Substantially EquivalentAutomated Testing Services, Ltd.
FDA 510(k) clearance K770823 for AUDIOMETRIC TESTING SYS., SERIES 500, Substantially Equivalent on 1977-05-18. Applicant: Automated Testing Services, Ltd..
Clearance details
- Applicant
- Automated Testing Services, Ltd.
- Product code
- Code EWO
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, 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.