OTICON

Hearing Aid, Air Conduction

OTICON, INC.

The following data is part of a premarket notification filed by Oticon, Inc. with the FDA for Oticon.

Pre-market Notification Details

• Device ID: K946045
• 510k Number: K946045
• Device Name: OTICON
• Classification: Hearing Aid, Air Conduction
• Applicant: OTICON, INC. 29 SCHOOLHOUSE RD. Somerset, NJ 08873
• Contact: Preben Brunved
• Correspondent: Preben Brunved; OTICON, INC. 29 SCHOOLHOUSE RD. Somerset, NJ 08873
• Product Code: ESD
• CFR Regulation Number: 874.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-12
• Decision Date: 1995-01-30