510(k) K251480
- Device
- PV01 PVDF Effort Sensor
- Applicant
- Neurotronics, LLC
- 510(k) number
- K251480
- Product code
- SFK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-29
- Date received
- 2025-05-13
- Regulation
- 882.1400
- Classification name
- Respiratory Effort Belt For Polysomnography
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- James Smith
- Address
- 13800 Tech City Cir., Suite 400 Alachua FL US 32615 32615
FDA Registration Numbers
- 1063925