K251480 is an FDA 510(k) clearance for the PV01 PVDF Effort Sensor. This device is classified as a Respiratory Effort Belt For Polysomnography (Class II - Special Controls, product code SFK).
Submitted by Neurotronics, LLC (Alachua, US). The FDA issued a Cleared decision on August 29, 2025, 108 days after receiving the submission on May 13, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 882.1400. To Assess Respiratory/breathing Effort By Measuring The Movement Of Chest And Abdominal Walls. The Belts Function As Accessories To Sleep/polysomnography (psg) And Home Sleep Apnea Test (hsat) Systems..
| 510(k) Number | K251480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2025 |
| Decision Date | August 29, 2025 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | SFK - Respiratory Effort Belt For Polysomnography |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | To Assess Respiratory/breathing Effort By Measuring The Movement Of Chest And Abdominal Walls. The Belts Function As Accessories To Sleep/polysomnography (psg) And Home Sleep Apnea Test (hsat) Systems. |