| Device Type ID | 581 |
| Device Name | Blender/mixer |
| Regulation Description | General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JRO |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 581 |
| Device | Blender/mixer |
| Product Code | JRO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use. |
| CFR Regulation Number | 862.2050 [🔎] |
| Device Problems | |
|---|---|
Overheating Of Device | 6 |
Thermal Decomposition Of Device | 2 |
Smoking | 1 |
| Total Device Problems | 9 |