Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 show TPLC since Back to Search Results
Device automatic event detection software for polysomnograph with 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
BEACON BIOSIGNALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENSODATA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HONEYNAPS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NEUMETRY MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
NEUROZONE MSH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NOX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1 1
Insufficient Information 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Superficial (First Degree) Burn 1 1

-
-