DEN240073
- 510(k) number
- DEN240073
- Device name
- PainChek (PainChek Adult)
- Applicant
- Painchek Limited (Ltd.) AU
- Product code
- SGB — Pain Assessment Software In Non-Communicative Adults
- Decision date
- 2025-10-06
- Date received
- 2024-12-11
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN240073
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.