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: K170209
• 510k Number: K170209
• 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-24
• Decision Date: 2017-02-23
• Summary: summary