PMA P810037S007
- Device
- KONTRON CUTANEOUS PCO2 MONITOR
- Applicant
- Kontron Cardiovascular
- PMA number
- P810037
- Supplement
- S007
- Product code
- LKD
- Decision date
- 1997-11-25
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Approval order statement
- Approval for modification of MicroGas 7640 with COMBI 81. The device, as modified, will be marketed under the trade name MicroGas 7650 with COMBI M82.
Current openFDA PMA Record
- Device
- KONTRON CUTANEOUS PCO2 MONITOR
- Applicant
- Kontron Cardiovascular
- PMA number
- P810037
- Supplement
- S007
- Product code
- LKD
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Decision date
- 1997-11-25
- Decision code
- APPR
- Date received
- 1996-09-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modification of MicroGas 7640 with COMBI 81. The device, as modified, will be marketed under the trade name MicroGas 7650 with COMBI M82.