DIGIFOCUS ITE— 510(k) K964683

Substantially Equivalent

Oticon, Inc.

FDA 510(k) clearance K964683 for DIGIFOCUS ITE, Substantially Equivalent on 1996-12-12. Applicant: Oticon, Inc..

Clearance details

Applicant: Oticon, Inc.
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1996-11-22
Decision date: 1996-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

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