Device Type ID | 5300 |
Device Name | Holder, Head, Radiographic |
Regulation Description | Radiographic Head Holder. |
Regulation Medical Specialty | Radiology |
Review Panel | Radiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 892.1920 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | IWY |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5300 |
Device | Holder, Head, Radiographic |
Product Code | IWY |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Radiographic Head Holder. |
CFR Regulation Number | 892.1920 [🔎] |