Proprietary Name: |
989803204301 Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line; 989803204311 Microstream™ Advance Neonatal-Infant Intubated CO2 Filter Line; 989803204321 Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line; 989803204331 Microstream™ Advance Adult-Pediatric CO2 Intubated Filter Line; 989803204341 Microstream™ Advance Neonatal-Infant Intubated CO2 Filter Line; 989803204511 Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line; 989803204521 Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line; 989803204531 Microstream™ Advance Neonatal-Infant Intubated CO2 Filter Line |
Classification Name: |
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
Product Code: |
CCK |
Device Class: |
2 |
Regulation Number: |
868.1400 |
Medical Specialty: |
Anesthesiology |
Registered Establishment Name: |
Philips North America LLC
|
Registered Establishment Number: |
1218950
|
Premarket Submission Number: |
K181467 |
Owner/Operator: |
Philips Medical Systems International BV |
Owner/Operator Number: |
1217116
|
Establishment Operations: |
Complaint File Establishment
|