FDA 510(k)

PV01 PVDF Effort Sensor

Número K: K251480 · 2025-08-29

Data da decisão2025-08-29

Código do produtoSFK

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PV01 PVDF Effort Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, LLC. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251480. The device is classified under product code SFK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PV01 PVDF Effort Sensor?

PV01 PVDF Effort Sensor is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Neurotronics, LLC. The 510(k) number is K251480.

When did PV01 PVDF Effort Sensor receive FDA 510(k) clearance?

PV01 PVDF Effort Sensor received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251480.

Who is the listed applicant for PV01 PVDF Effort Sensor?

The FDA 510(k) record lists Neurotronics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PV01 PVDF Effort Sensor?

The FDA product code for PV01 PVDF Effort Sensor is SFK.

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