OMEGA 21 SYSTEM— 510(k) K973683
Substantially Equivalent for Some IndicationsEbi Electro Biology
FDA 510(k) clearance K973683 for OMEGA 21 SYSTEM, Substantially Equivalent for Some Indications on 1997-12-24. Applicant: Ebi Electro Biology.
Clearance details
- Applicant
- Ebi Electro Biology
- Product code
- Code MNH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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.