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 uterine electromyographic monitor
Regulation Description External uterine contraction monitor and accessories.
Definition The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
Product CodeOSP
Regulation Number 884.2720
Device Class 2


Premarket Reviews
ManufacturerDecision
OBMEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 1 1
Patient Data Problem 1 1
Device Sensing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Diminished Pulse Pressure 1 1
Skin Tears 1 1

-
-