FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Bone Sonometer
PMA: P970040
·
Supplement: S003
·
Decision Jul 30, 2004
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Bone Sonometer
- Trade Name
- ACHILLES EXPRESS ULTRASONOMETER
- PMA Number
- P970040
- Supplement Number
- S003
- Device Class
- FDA Class 2
- Product Code
- MUA
- Generic Name
- Bone sonometer
- Regulation Number
- 892.1180
- Medical Specialty
- Radiology
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 30, 2004
- Date Received
- July 15, 2004
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Express GMP Supplement
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT GE MEDICAL SYSTEMS CHINA CO., LTD., JIANSGU, P.R. CHINA.
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 |
|---|---|---|---|
| MUA | Bone Sonometer | FDA class 2 | Radiology |