PV01 PVDF Effort Sensor
FDA 510(k) K251480 · Neurotronics, LLC
510(k) numberK251480
Submission
- Device name
- PV01 PVDF Effort Sensor
- Applicant
- Neurotronics, LLC
Alachua, FL, US - Received
- May 13, 2025
- Decision date
- August 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SFK – Respiratory Effort Belt For Polysomnography
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
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.
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Questions and answers
When was PV01 PVDF Effort Sensor cleared by the FDA?
PV01 PVDF Effort Sensor (K251480) received a 510(k) decision of Substantially Equivalent on August 29, 2025, 108 days after the submission was received.
What is the product code of K251480?
The FDA product code is SFK – Respiratory Effort Belt For Polysomnography, a Class II (moderate risk) device regulated under 21 CFR 882.1400.