FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stimulator, Fetal, Acoustic
PMA: P870025
·
Supplement: S001
·
Decision Oct 20, 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
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- MCP
- Generic Name
- Stimulator, fetal, acoustic
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 20, 1988
- Date Received
- October 11, 1988
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Other
- Expedited Review
- N
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 |