- Device
- COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR
- Applicant
- Ge Medical Systems, Inc.
- PMA number
- P870025
- Supplement
- S004
- Product code
- MCP
- Generic name
- Stimulator, fetal, acoustic
- Decision date
- 1996-02-01
- Decision code
- APPR
- Date received
- 1995-11-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES IN THE QUALITY CONTROL AND MANUFACUTRING PRACTICES FOR THE TRANSDUCER IN COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR