FDA · official record DEN210027UnknownThe Cooral System
United StatesQUABraincool AB
Official record identity
- FDA application number
- DEN210027
- Decision date
- October 14, 2022
- Published decision
- Unknown
Classification
Published parties
- Applicant
- Braincool AB
Additional source fields
- Decision code
- DENG
- Published decision
- Unknown
- Submission type
- Direct
- Received date
- 2021-07-02
- Review panel
- Dental
- Current product-code class (harmonized)
- 2
- Current product-code regulation (harmonized)
- 872.5590
About this record
This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.