• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device automatic event detection software for polysomnograph with electroencephalograph
Regulation Description Electroencephalograph.
Definition Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
Product CodeOLZ
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
OXFORD BIOSIGNALS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 2

-
-