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