• 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 full-montage electroencephalograph
Regulation Description Electroencephalograph.
Definition Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
Product CodeOMB
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
CADWELL
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Use of Device Issue 1
Total Device Problems 1

-
-