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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 the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, Inc.. It received FDA 510(k) clearance on 2018-11-16 under 510(k) 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. The listed applicant is Neurotronics, Inc.. The 510(k) number is K181709.

When did Serenity Piezo Sensor, Serenity Thermocouple Sensor receive FDA 510(k) clearance?

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

Who is the listed applicant for Serenity Piezo Sensor, Serenity Thermocouple Sensor?

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

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 records listing Neurotronics, Inc. as applicant

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Related Devices (Code: OLV)

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Official Source

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