FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
K Number: K072439
·
Decision Sep 14, 2007
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
7
Review Days
15
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Basic Information
- Device Name
- GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
- K Number
- K072439
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems Ultrasound and Primary Care Dia
- Date Received
- August 30, 2007
- Decision Date
- September 14, 2007
- Product Code
- KGI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGI | Densitometer, Bone | FDA class 2 | Radiology |
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