PainChek (PainChek Adult)— 510(k) DEN240073
UnknownPainchek Limited (Ltd.)
FDA 510(k) clearance DEN240073 for PainChek (PainChek Adult), Unknown on 2025-10-06. Applicant: Painchek Limited (Ltd.). Device class: 2.
Clearance details
- Applicant
- Painchek Limited (Ltd.)
- Product code
- Code SGB
- Device class
- Class 2
- Regulation
- 21 CFR 882.1472
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Sydney, AU
Data sourced from openFDA. This site is unofficial and independent of the FDA.