DUALINE 100 BTE— 510(k) K973948

Substantially Equivalent

Bernafon-Maico, Inc.

FDA 510(k) clearance K973948 for DUALINE 100 BTE, Substantially Equivalent on 1997-10-28. Applicant: Bernafon-Maico, Inc..

Clearance details

Applicant: Bernafon-Maico, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1997-10-16
Decision date: 1997-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.