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 standard polysomnograph with electroencephalograph
Definition 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.
Product CodeOLV
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEREBRA MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOMNOMEDICS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 3 3
2022 3 3
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 3 3
Computer Software Problem 2 2
Excessive Heating 2 2
Mechanical Problem 1 1
Electro-Static Discharge 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
No Consequences Or Impact To Patient 1 1

-
-