FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
PLANMECA ROMEXIS
K Number: K140713
·
Decision Jun 16, 2014
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
28
Review Days
87
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Basic Information
- Device Name
- PLANMECA ROMEXIS
- K Number
- K140713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Planmeca Oy
- Date Received
- March 21, 2014
- Decision Date
- June 16, 2014
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K091197 | PLANMECA PROSENSOR | Jul 29, 2009 | Substantially Equivalent |
| K072244 | PLANMECA PROONE | Sep 21, 2007 | Substantially Equivalent |
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