MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT— 510(k) K964132
Substantially EquivalentBio-Logic Systems Corp.
FDA 510(k) clearance K964132 for MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT, Substantially Equivalent on 1997-05-13. Applicant: Bio-Logic Systems Corp..
Clearance details
- Applicant
- Bio-Logic Systems Corp.
- Product code
- Code EWO
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mudelein, 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.