OLV · Class II · 21 CFR 882.1400

FDA Product Code OLV: Standard Polysomnograph With Electroencephalograph

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.

Leading manufacturers include Nihon Kohden America, Inc., Neurotronics, Inc. and Bio-Logic Systems Corp..

65
Total
65
Cleared
122d
Avg days
1986
Since
65 devices
25–48 of 65
Cleared Sep 30, 2004
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
K042364
Lamont Medical, Inc.
Neurology · 30d
Cleared Jan 07, 2004
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
K033475
Nihon Kohden America, Inc.
Neurology · 65d
Cleared Sep 10, 2002
XLTEK SLEEP SYSTEM
K022037
Excel Tech. , Ltd.
Neurology · 78d
Cleared Jul 29, 2002
PSG INPUT BOX, MODEL JE-912AK
K022121
Nihon Kohden America, Inc.
Neurology · 28d
Cleared Aug 02, 2001
SOMNO STAR & SERIES SLEEP SYSTEM
K012085
Sensor Medics Corp.
Neurology · 30d
Cleared May 08, 2001
NEUROFAX, MODELS EEG-1100A, EEG-9100A
K011204
Nihon Kohden America, Inc.
Neurology · 19d
Cleared Dec 21, 2000
BIO-LOGIC SLEEPSCAN NETLINK
K003681
Bio-Logic Systems Corp.
Neurology · 21d
Cleared May 16, 2000
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K001013
Airsep Corp.
Neurology · 48d
Cleared Apr 26, 2000
VITAPORT 3
K000338
Nihon Kohden America, Inc.
Neurology · 83d
Cleared Mar 06, 2000
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
K994142
Grass Instrument Co.
Neurology · 89d
Cleared Oct 14, 1999
NEUROFAX, MODEL EEG-1100A
K992742
Nihon Kohden America, Inc.
Neurology · 59d
Cleared Aug 27, 1999
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K992283
Airsep Corp.
Neurology · 51d
Cleared Aug 06, 1999
H20- TETHERED OPTION
K992291
Grass-Telefactor Product Group
Neurology · 30d
Cleared Jul 23, 1999
BIOSACA SYSTEM, MODEL 800
K991446
Biosys AB (Publ)
Neurology · 88d
Cleared Jul 12, 1999
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
K991900
Excel Tech. , Ltd.
Neurology · 38d
Cleared May 19, 1999
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
K990522
Lamont Medical, Inc.
Neurology · 90d
Cleared Mar 12, 1999
BIOSACA SYSTEM
K984580
Biosys AB (Publ)
Neurology · 79d
Cleared Dec 01, 1998
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K983072
Nihon Kohden America, Inc.
Neurology · 90d
Cleared Nov 25, 1998
MODIFICATION TO BIO-LOGIC SLEEPSCAN
K983913
Bio-Logic Systems Corp.
Neurology · 21d
Cleared Jun 09, 1998
DEEGLITE
K974583
Grass-Telefactor Product Group
Neurology · 203d
Cleared Mar 09, 1998
H2O
K974587
Grass-Telefactor Product Group
Neurology · 90d
Cleared Jan 16, 1998
EMBLA
K971813
Ferguson Medical
Neurology · 245d
Cleared Aug 13, 1997
ALICE 4R SYSTEM
K971867
Healthdyne Technologies, Inc.
Neurology · 85d
Cleared May 19, 1997
GRASS BRAINWAVE SOFTWARE
K970951
Astro-Med, Inc.
Neurology · 66d