PMA P810037S010

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).