ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS— 510(k) K031986
Substantially EquivalentIcs Medical
FDA 510(k) clearance K031986 for ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS, Substantially Equivalent on 2003-07-24. Applicant: Ics Medical.
Clearance details
- Applicant
- Ics Medical
- Product code
- Code EWO
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Schaumburg, 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.