Device Type ID | 5262 |
Device Name | System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use) |
Regulation Description | Liquid Crystal Thermographic System. |
Regulation Medical Specialty | Obstetrics/Gynecology |
Review Panel | Radiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 884.2982 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KYA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |