Serenity Piezo Sensor, Serenity Thermocouple Sensor
FDA 510(k) K181709 · Neurotronics, Inc.
510(k) numberK181709
Submission
- Device name
- Serenity Piezo Sensor, Serenity Thermocouple Sensor
- Applicant
- Neurotronics, Inc.
Gainesville, FL, US - Received
- June 28, 2018
- Decision date
- November 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLV – Standard Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
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Questions and answers
When was Serenity Piezo Sensor, Serenity Thermocouple Sensor cleared by the FDA?
Serenity Piezo Sensor, Serenity Thermocouple Sensor (K181709) received a 510(k) decision of Substantially Equivalent on November 16, 2018, 141 days after the submission was received.
What is the product code of K181709?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.