DeviceClearance

K082206

Substantially Equivalent

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES

Applicant
Helix Medical, LLC
Product code
EWL
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Carpinteria, CA, US
Download summary PDF View on FDA.gov ↗

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.