FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Bone Sonometer
PMA: P990035
·
Supplement: S002
·
Decision Jul 27, 2001
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Bone Sonometer
- Trade Name
- SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER
- PMA Number
- P990035
- Supplement Number
- S002
- 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 27, 2001
- Date Received
- June 26, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Express GMP Supplement
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT SUNLIGHT MEDICAL LTD., TEL-AVIV, ISRAEL.
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 |