- Device
- COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR
- Applicant
- Ge Medical Systems, Inc.
- PMA number
- P870025
- Supplement
- S005
- Product code
- MCP
- Generic name
- Stimulator, fetal, acoustic
- Decision date
- 1996-07-17
- Decision code
- APPR
- Date received
- 1996-02-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO PERMIT INTERFACE OF THE COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR WITH THE COROMETRICS MODEL 155 FETAL MONITOR