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
Cleared
Jan 17, 1997
MEDILOG MPA-S
Oxford Instruments Medical Systems
Neurology
263d
Cleared
Jul 06, 1994
ALICE
Healthdyne, Inc.
Neurology
792d
Cleared
Aug 12, 1986
ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.
Oxford Medilog, Inc.
Neurology
188d
Cleared
Jun 05, 1986
4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
Nihon Kohden America, Inc.
Neurology
197d