FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
K Number: K021372
·
Decision Jun 7, 2002
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
9
Applicant Total
52
Review Days
38
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Basic Information
- Device Name
- VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
- K Number
- K021372
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1830
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J. Morita USA, Inc.
- Date Received
- April 30, 2002
- Decision Date
- June 7, 2002
- Product Code
- EAG
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| EAG | Cephalometer | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EAG), ordered by most recent decision date.
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC
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FDA Class 2
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GX CEPH
FDA 510(k)
FDA Class 2
·Dental
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