510(k) DEN240073
- Device
- PainChek (PainChek Adult)
- Applicant
- Painchek Limited (Ltd.)
- 510(k) number
- DEN240073
- Product code
- SGB
- Decision
- Unknown (DENG)
- Decision date
- 2025-10-06
- Date received
- 2024-12-11
- Regulation
- 882.1472
- Classification name
- Pain Assessment Software In Non-Communicative Adults
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Caleb Ng
- Address
- Suite 401, 35 Lime St. Sydney AU 2000 2000
FDA Registration Numbers
- 3022518366
Source Documents
510(k) summary PDF not indicated by FDA