GENESIS II

Echocardiograph

BIOSOUND, INC.

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

Pre-market Notification Details

• Device ID: K871697
• 510k Number: K871697
• Device Name: GENESIS II
• Classification: Echocardiograph
• Applicant: BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250
• Contact: Robert Courtney
• Correspondent: Robert Courtney; BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250
• Product Code: DXK
• CFR Regulation Number: 870.2330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-04-30
• Decision Date: 1987-11-06