HERO

Electrocardiograph

MEDICAL PREDICTIVE SCIENCE CORP.

The following data is part of a premarket notification filed by Medical Predictive Science Corp. with the FDA for Hero.

Pre-market Notification Details

• Device ID: K111601
• 510k Number: K111601
• Device Name: HERO
• Classification: Electrocardiograph
• Applicant: MEDICAL PREDICTIVE SCIENCE CORP. 2246 IVY RD., SUITE 17 Charlottesville, VA 22903
• Contact: Will King
• Correspondent: Will King; MEDICAL PREDICTIVE SCIENCE CORP. 2246 IVY RD., SUITE 17 Charlottesville, VA 22903
• Product Code: DPS
• CFR Regulation Number: 870.2340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-08
• Decision Date: 2011-07-08
• Summary: summary