CAPELLA

Audiometer

MADSEN ELECTRONICS, INC.

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

Pre-market Notification Details

• Device ID: K002200
• 510k Number: K002200
• Device Name: CAPELLA
• Classification: Audiometer
• Applicant: MADSEN ELECTRONICS, INC. 5600 ROWLAND RD., SUITE 275 Minnetonka, MN 55343
• Contact: Jim Bergerson
• Correspondent: Jim Bergerson; MADSEN ELECTRONICS, INC. 5600 ROWLAND RD., SUITE 275 Minnetonka, MN 55343
• Product Code: EWO
• CFR Regulation Number: 874.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-07-20
• Decision Date: 2000-08-25