• 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 cranial measurement software
Regulation Description Manual surgical instrument for general use.
Definition Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods.
Product CodeQQO
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
PEDIAMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-