The following data is part of a premarket notification filed by Impact Applications, Inc. with the FDA for Impact Quick Test.
Device ID | K170551 |
510k Number | K170551 |
Device Name: | ImPACT Quick Test |
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 | 2017-02-24 |
Decision Date | 2017-06-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00864127000325 | K170551 | 000 |
00864127000356 | K170551 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IMPACT QUICK TEST 87977941 5537423 Live/Registered |
ImPACT Applications, Inc. 2016-08-04 |
IMPACT QUICK TEST 87328913 5746036 Live/Registered |
ImPACT Applications, Inc. 2017-02-08 |
IMPACT QUICK TEST 87127120 5530843 Live/Registered |
ImPACT Applications, Inc. 2016-08-04 |