PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT— 510(k) K011619
Substantially EquivalentPlanmeca Oy
FDA 510(k) clearance K011619 for PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT, Substantially Equivalent on 2001-06-29. Applicant: Planmeca Oy. Device class: 2.
Clearance details
- Applicant
- Planmeca Oy
- Product code
- Code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Addison, IL, US
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