KONTRON CUTANEOUS PCO2 MONITOR
FDA premarket approval P810037/S007 · decided 1997-11-25
Approval details
- PMA number
- P810037
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KONTRON CUTANEOUS PCO2 MONITOR
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Applicant
- Kontron Cardiovascular
- Date received
- 1996-09-18
- Decision date
- 1997-11-25
- Days to decision
- 433 days
- Decision code
- APPR
- Product code
- LKD
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Everett, MA
- 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.
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