BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES— 510(k) K082206
Substantially EquivalentHelix Medical, LLC
FDA 510(k) clearance K082206 for BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES, Substantially Equivalent on 2008-09-04. Applicant: Helix Medical, LLC.
Clearance details
- Applicant
- Helix Medical, LLC
- Product code
- Code EWL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Carpinteria, CA, US
Adverse events under product code EWL
product code EWL- Death
- 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.