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

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFETAL ACOUSTIC STIMULATOR
Classification Namestimulator, fetal, acoustic
Generic Namefetal acoustic stimulator
ApplicantGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
PMA NumberP870025
Supplement NumberS008
Date Received08/01/2005
Decision Date03/02/2006
Product Code
MCP[ Registered Establishments with MCP ]
Advisory Committee Obstetrics/Gynecology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for vendor changes for the following components: die cast frame and printed circuit board (pcb) and a change in adhesive material.
-
-