HERO

Electrocardiograph

MEDICAL DECISION NETWORKS

The following data is part of a premarket notification filed by Medical Decision Networks with the FDA for Hero.

Pre-market Notification Details

• Device ID: K021230
• 510k Number: K021230
• Device Name: HERO
• Classification: Electrocardiograph
• Applicant: MEDICAL DECISION NETWORKS 2300 COMMONWEALTH DR. Charlottesville, VA 22901
• Contact: William E King
• Correspondent: William E King; MEDICAL DECISION NETWORKS 2300 COMMONWEALTH DR. Charlottesville, VA 22901
• Product Code: DPS
• CFR Regulation Number: 870.2340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-04-18
• Decision Date: 2003-05-09
• Summary: summary