510(k) K181223
K181223 is an FDA 510(k) premarket notification submitted by Impact Applications, Inc. for the device "ImPACT". The FDA issued a decision of Substantially Equivalent on October 20, 2018. The device falls under product code POM (Computerized Cognitive Assessment Aid For Concussion), a Class II device regulated under 21 CFR 882.1471. Impact Applications, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2018
- Date Received
- May 8, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computerized Cognitive Assessment Aid For Concussion
- Device Class
- Class II
- Regulation Number
- 882.1471
- Review Panel
- NE
- Submission Type
For use as an assessment aid in the management of concussion.