KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505
FDA premarket approval P810037/S010 · decided 1998-05-22
Approval details
- PMA number
- P810037
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Applicant
- Kontron Cardiovascular
- Date received
- 1997-03-14
- Decision date
- 1998-05-22
- Days to decision
- 434 days
- Decision code
- APPR
- Product code
- LKD
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Everett, MA
- 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).
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