Device Listing 1051065226
Listing Summary#
- Listing key
- 1051065226
- Premarket submission
- K160415
- Device
- GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
- Applicant
- Instrumentation Laboratory CO
- Product code
- GKF
- Decision date
- 2016-12-14