| Device Type ID | 1669 |
| Device Name | Analyzer, Body Composition |
| Regulation Description | Impedance Plethysmograph. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2770 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MNW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1669 |
| Device | Analyzer, Body Composition |
| Product Code | MNW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Impedance Plethysmograph. |
| CFR Regulation Number | 870.2770 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOSPACE CORPORATION LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONMO ELECTRONIC COMPANY LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JAWON MEDICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Burst Container Or Vessel | 1 |
| Total Device Problems | 1 |