Device Type ID | 5253 |
Device Name | Cephalometer |
Regulation Description | Cephalometer. |
Regulation Medical Specialty | Dental |
Review Panel | Radiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 872.1830 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | EAG |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 5253 |
Device | Cephalometer |
Product Code | EAG |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Cephalometer. |
CFR Regulation Number | 872.1830 [🔎] |