• 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 monitor, uterine contraction, external (for use in clinic)
Regulation Description External uterine contraction monitor and accessories.
Product CodeHFM
Regulation Number 884.2720
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTREX, INC.
  SUBSTANTIALLY EQUIVALENT 2

-
-