ImPACT Quick Test

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 Quick Test.

Pre-market Notification Details

Device IDK170551
510k NumberK170551
Device Name:ImPACT Quick Test
ClassificationComputerized Cognitive Assessment Aid For Concussion
Applicant ImPACT Applications, Inc. 9665 Granite Ridge Drive, Suite 550 San Diego,  CA  92123
ContactMichael Zagorski
CorrespondentMichael Zagorski
ImPACT Applications, Inc. 9665 Granite Ridge Drive, Suite 550 San Diego,  CA  92123
Product CodePOM  
CFR Regulation Number882.1471 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-24
Decision Date2017-06-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00864127000325 K170551 000
00864127000356 K170551 000

Trademark Results [ImPACT Quick Test]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMPACT QUICK TEST
IMPACT QUICK TEST
87977941 5537423 Live/Registered
ImPACT Applications, Inc.
2016-08-04
IMPACT QUICK TEST
IMPACT QUICK TEST
87328913 5746036 Live/Registered
ImPACT Applications, Inc.
2017-02-08
IMPACT QUICK TEST
IMPACT QUICK TEST
87127120 5530843 Live/Registered
ImPACT Applications, Inc.
2016-08-04

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