ImPACT

Computerized Cognitive Assessment Aid For Concussion

ImPACT Applications, Inc.

The following data is part of a premarket notification filed by Impact Applications, Inc. with the FDA for Impact.

Pre-market Notification Details

• Device ID: K181223
• 510k Number: K181223
• Device Name: ImPACT
• Classification: Computerized Cognitive Assessment Aid For Concussion
• Applicant: ImPACT Applications, Inc. 9665 Granite Ridge Drive, Suite 550 San Diego, CA 92123
• Contact: Michael Zagorski
• Correspondent: Michael Zagorski; ImPACT Applications, Inc. 9665 Granite Ridge Drive, Suite 550 San Diego, CA 92123
• Product Code: POM
• CFR Regulation Number: 882.1471 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-05-08
• Decision Date: 2018-10-20
• Summary: summary