FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
K Number: K980581
·
Decision Apr 17, 1998
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
28
Review Days
59
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Basic Information
- Device Name
- PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
- K Number
- K980581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Planmeca Oy
- Date Received
- February 17, 1998
- Decision Date
- April 17, 1998
- 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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