Device Type ID | 5377 |
Device Name | Cradle, Patient, Radiologic |
Regulation Description | Radiologic Patient Cradle. |
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 | 892.1830 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KXH |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5377 |
Device | Cradle, Patient, Radiologic |
Product Code | KXH |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Radiologic Patient Cradle. |
CFR Regulation Number | 892.1830 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Med Tec Inc | II | Aug-29-2017 |