FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Stimulator, Fetal, Acoustic
PMA: P870025
·
Decision Aug 31, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Stimulator, Fetal, Acoustic
- Trade Name
- FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY
- PMA Number
- P870025
- Device Class
- FDA Class 3
- Product Code
- MCP
- Generic Name
- Stimulator, fetal, acoustic
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- August 31, 1988
- Date Received
- May 20, 1987
- Expedited Review
- N
- Docket Number
- 88M-0346
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCP | Stimulator, Fetal, Acoustic | FDA class 3 | Unknown |