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FDA 510(k)

PV01 PVDF Effort Sensor

K-Number: K251480 · 2025-08-29

ApplicantNeurotronics, LLC
Decision Date2025-08-29
Product CodeSFK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Neurotronics, LLC. The 510(k) number is K251480.

When was PV01 PVDF Effort Sensor approved by the FDA?

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

What company makes PV01 PVDF Effort Sensor?

PV01 PVDF Effort Sensor is manufactured by Neurotronics, LLC.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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