PMA P870025S010

Device
FETAL ACOUSTIC STIMULATOR
Applicant
Ge Medical Systems, Inc.
PMA number
P870025
Supplement
S010
Product code
MCP
Decision date
2011-10-12
Generic name
Stimulator, fetal, acoustic
Approval order statement
CHANGES TO THE SUPPLIERS FOR COMPONENTS OF THE FAST DEVICE.

Current openFDA PMA Record#

Device
FETAL ACOUSTIC STIMULATOR
Applicant
Ge Medical Systems, Inc.
PMA number
P870025
Supplement
S010
Product code
MCP
Generic name
Stimulator, fetal, acoustic
Decision date
2011-10-12
Decision code
OK30
Date received
2011-09-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES TO THE SUPPLIERS FOR COMPONENTS OF THE FAST DEVICE.