Q-Collar
FDA 510(k) clearance DEN200017 · decided 2021-02-26
Clearance details
- K-number
- DEN200017
- Device name
- Q-Collar
- Applicant
- Q30 Sports Science, LLC
- Decision
- Unknown
- Date received
- 2020-03-19
- Decision date
- 2021-02-26
- Days to decision
- 344 days
- Clearance type
- Direct
- Product code
- QNX
- Device class
- 2
- Regulation number
- 890.3050
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Westport, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.