What is FDA product code OLV?

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.

Neurology › DiagnosticStandard Polysomnograph With Electroencephalograph

Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m

Name: Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m
Brand: Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m

The Serenity BP01 Body Position Sensor measures a patient’s orientation during a polysomnography study. Worn by the patient and connected to a compatible amplifier, it provides position…

Registry build 21.09.26

The Serenity BP01 Body Position Sensor measures a patient’s orientation during a polysomnography study. Worn by the patient and connected to a compatible amplifier, it provides position information for recording alongside other sleep study signals and review by a qualified sleep clinician.

A three-axis accelerometer detects five orientations: upright or sitting, lying on the back, lying face down, left side and right side. The sensor outputs a voltage corresponding to the detected position. The connected polysomnography system conditions, records and displays the signal.

Supervised Sleep Studies

The sensor is intended for adults and children in hospitals, laboratories, clinics and nursing homes, or elsewhere under medical direction. It does not trigger alarms and is not intended for high-risk life monitoring or as a critical component of an apnea or alarm system.

1manufacturer

1catalogue number

5510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OLV
Manufacturer	City	Province	Registered as	Device types
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13

Record

Regulatory record for Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m
Listed by	Neurotronics, LLC, United States
FDA product code	OLV
Device type	Standard Polysomnograph With Electroencephalograph
Device class	Class 2
Regulation	21 CFR 882.1400
Establishment	Manufacturer
510(k)	K173868
Record published	2018-11-08
Record revised	2025-09-24 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m
Catalogue number	Size	Status
BP01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Alice 6	Respironics Inc.	58
Somnostar	Carefusion	28
Standard Polysomnograph With Electroencephalograph	Nihon Kohden America, Inc.	18
Standard Polysomnograph With Electroencephalograph	Nihon Kohden Corp.	17
Sleep Profiler PSG2	Advanced Brain Monitoring, Inc.	10
Sleep Profiler	Advanced Brain Monitoring, Inc.	8
Trackit Sleepwalker	Lifelines Ltd.	8
micromed	Micromed, Inc.	7
Compumedics Grael	Compumedics Limited	6
Neurovirtual	Neurovirtual USA, Inc.	4
Pro-Flow	Respironics Inc.	3
Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 2.0m	Neurotronics, LLC	3

Showing 12 of 89. All products under Standard Polysomnograph With Electroencephalograph

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181709	2018-11-16
K173868	2018-07-02
K161650	2017-01-19
K142774	2015-02-18
K131415	2013-08-09

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.