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FDA 510(k)

Serenity Body Position Sensor, Serenity RIP Sensors

K-Number: K173868 · 2018-07-02

ApplicantNeurotronics, Inc.
Decision Date2018-07-02
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Serenity Body Position Sensor, Serenity RIP Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, Inc.. It received FDA 510(k) clearance on 2018-07-02 under 510(k) number K173868. 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 Body Position Sensor, Serenity RIP Sensors?

Serenity Body Position Sensor, Serenity RIP Sensors is a medical device that received FDA 510(k) clearance on 2018-07-02. The listed applicant is Neurotronics, Inc.. The 510(k) number is K173868.

When did Serenity Body Position Sensor, Serenity RIP Sensors receive FDA 510(k) clearance?

Serenity Body Position Sensor, Serenity RIP Sensors received FDA 510(k) clearance on 2018-07-02, under 510(k) number K173868.

Who is the listed applicant for Serenity Body Position Sensor, Serenity RIP Sensors?

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 Body Position Sensor, Serenity RIP Sensors?

The FDA product code for Serenity Body Position Sensor, Serenity RIP Sensors is OLV.

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Official Source

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