FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORTABLE X-RAY SYSTEM
K Number: K122124
·
Decision May 16, 2013
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
68
Review Days
302
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Basic Information
- Device Name
- PORTABLE X-RAY SYSTEM
- K Number
- K122124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osstem Implant Co., Ltd.
- Date Received
- July 18, 2012
- Decision Date
- May 16, 2013
- Product Code
- EHD
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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