Medilog Mpa-S

FDA 510(k) K961638 · Oxford Instruments Medical Systems

Substantially Equivalent

510(k) numberK961638

Submission

Device name
Medilog Mpa-S
Applicant
Oxford Instruments Medical Systems
Clearwater, FL, US
Received
April 29, 1996
Decision date
January 17, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

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.

Other 510(k)s with product code OLV

510(k)DeviceApplicantDecision
K261747Report StudioOLV · Traditional Beacon Biosignals, Inc.08/25/2026SE
K260585Noxturnal WebOLV · Special Nox Medical Ehf03/20/2026SE
K242447Falcon HSTOLV · Traditional Compumedics Limited02/20/2025SE
K241288Noxturnal WebOLV · Traditional Nox Medical Ehf12/23/2024SE
K240700HomeSleepTest (HST, HST REM+)OLV · Traditional Somnomedics GmbH12/08/2024SE
K213007Cerebra Sleep SystemOLV · Traditional Cerebra Medical , Ltd.07/06/2022SE
K201054SOMNOscreen plusOLV · Traditional Somnomedics GmbH08/12/2020SE
K192624ApneaTrakOLV · Traditional Cadwell Industries, Inc.02/20/2020SE
K181709Serenity Piezo Sensor, Serenity Thermocouple SensorOLV · Traditional Neurotronics, Inc.11/16/2018SE
K173868Serenity Body Position Sensor, Serenity RIP SensorsOLV · Traditional Neurotronics, Inc.07/02/2018SE

More from Neurotronics, Inc.

510(k)DeviceDecision
K992607Sonicaid System 8002HGM · Traditional 04/27/2001SE
K984052Synergy Iom SystemIKN · Traditional 05/17/1999SE
K970902Medilog FD4DSH · Traditional 05/05/1997SE
K943862Sonicaid Model MR-63 Ambulatory ECG RecorderDSH · Traditional 06/07/1995SE

Questions and answers

When was Medilog Mpa-S cleared by the FDA?

Medilog Mpa-S (K961638) received a 510(k) decision of Substantially Equivalent on January 17, 1997, 263 days after the submission was received.

What is the product code of K961638?

The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.