PMA P810037
- Device
- KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505
- Applicant
- KONTRON CARDIOVASCULAR
- PMA number
- P810037
- Supplement
- S010
- Product code
- LKD
- Decision date
- 1998-05-22
- Generic name
- Monitor, Carbon-dioxide, Cutaneous
- Approval order statement
- Approval For Converstion Of The Stand-alone MicroGas 7640 P02/PC02 Monitor To A Plug-in Module For The Kolormon Plus Host. The Device, As Modified, Will Be Marketed Under The Trade Name Kontron Kolormon Plus BloodGas Module 7267-505 And Is Indicated For Cutaneous Measurement Of Blood Gas Tensions (P02 Or PC02).
Current openFDA PMA Record
- Device
- KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505
- Applicant
- Kontron Cardiovascular
- PMA number
- P810037
- Supplement
- S010
- Product code
- LKD
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Decision date
- 1998-05-22
- Decision code
- APPR
- Date received
- 1997-03-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for converstion of the stand-alone MicroGas 7640 P02/PC02 Monitor to a plug-in module for the Kolormon Plus host. The device, as modified, will be marketed under the trade name Kontron Kolormon Plus BloodGas Module 7267-505 and is indicated for cutaneous measurement of blood gas tensions (P02 or PC02).