Device Type ID | 5435 |
Device Name | Applicator, Hyperthermia, Superficial, Rf/microwave |
Review Panel | Radiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | LNC |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5435 |
Device | Applicator, Hyperthermia, Superficial, Rf/microwave |
Product Code | LNC |
FDA Device Classification | Class 3 Medical Device |