COSMOS

Electrocardiograph

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Cosmos.

Pre-market Notification Details

• Device ID: K823220
• 510k Number: K823220
• Device Name: COSMOS
• Classification: Electrocardiograph
• Applicant: NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601
• Product Code: DPS
• CFR Regulation Number: 870.2340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-11-01
• Decision Date: 1982-11-24