| Device Type ID | 765 |
| Device Name | Plethysmograph, Impedance |
| Regulation Description | Impedance Plethysmograph. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| 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 | DSB |
| 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 | 765 |
| Device | Plethysmograph, Impedance |
| Product Code | DSB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Impedance Plethysmograph. |
| CFR Regulation Number | 870.2770 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMPEDIMED LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NONINVASIVE MEDICAL TECHNOLOGIES, | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SENSIBLE MEDICAL INNOVATIONS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VASOCOM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Partners In Medicine Llc | II | Jan-04-2016 |