510(k) DEN200017
DEN200017 is an FDA 510(k) premarket notification submitted by Q30 Sports Science, LLC for the device "Q-Collar". The FDA issued a decision of De Novo Granted on February 26, 2021. The device falls under product code QNX (External Compression Device For Internal Jugular Vein Compression), a Class II device regulated under 21 CFR 890.3050.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 26, 2021
- Date Received
- March 19, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Compression Device For Internal Jugular Vein Compression
- Device Class
- Class II
- Regulation Number
- 890.3050
- Review Panel
- PM
- Submission Type
External compression device for internal jugular vein compression. An external compression device for internal jugular vein compression is a non-invasive device that is intended to increase intracranial blood volume to reduce the occurrence of specific changes in the brain following head impacts sustained from the environment of use.