FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Bone Sonometer
PMA: P990035
·
Supplement: S005
·
Decision Nov 17, 2003
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Bone Sonometer
- Trade Name
- OMNISENSE 7000S ULTRASOUND BONE SONOMETER
- PMA Number
- P990035
- Supplement Number
- S005
- 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
- November 17, 2003
- Date Received
- December 21, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZICON LTD., PETAH-TIKVA, 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 |