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FDA 510(k)

Serenity Piezo Sensor, Serenity Thermocouple Sensor

K-Number: K181709 · 2018-11-16

ApplicantNeurotronics, Inc.
Decision Date2018-11-16
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Serenity Piezo Sensor, Serenity Thermocouple Sensor is a medical device manufactured by Neurotronics, Inc.. It received FDA 510(k) clearance on 2018-11-16 under approval number K181709. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Serenity Piezo Sensor, Serenity Thermocouple Sensor?

Serenity Piezo Sensor, Serenity Thermocouple Sensor is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Neurotronics, Inc.. The 510(k) number is K181709.

When was Serenity Piezo Sensor, Serenity Thermocouple Sensor approved by the FDA?

Serenity Piezo Sensor, Serenity Thermocouple Sensor received FDA 510(k) clearance on 2018-11-16, under approval number K181709.

What company makes Serenity Piezo Sensor, Serenity Thermocouple Sensor?

Serenity Piezo Sensor, Serenity Thermocouple Sensor is manufactured by Neurotronics, Inc..

What is the FDA product code for Serenity Piezo Sensor, Serenity Thermocouple Sensor?

The FDA product code for Serenity Piezo Sensor, Serenity Thermocouple Sensor is OLV.

Other Devices by Neurotronics, Inc.

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Official Source

View on FDA Database →

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

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