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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803204351 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204361 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204371 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204381 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204391 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204401 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204411 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204421 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line; 989803204431 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line; 989803204441 Microstream™ Advance Neonatal-Infant Nasal CO2 Filter Line; 989803204481 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204491 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204501 Microstream™ Advance Pediatric Nasal CO2 Filter Line; 989803204541 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204551 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204561 Microstream™ Advance Pediatric Oral-Nasal CO2 Filter Line; 989803204571 Microstream™ Advance Adult Oral-Nasal CO2 Filter Line; 989803204581 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204591 Microstream™ Advance Pediatric Nasal CO2 Filter Line; 989803204601 Microstream™ Advance Pediatric Nasal CO2 Filter Line; 989803204611 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204621 Microstream™ Advance Adult Nasal CO2 Filter Line; 989803204631 Microstream™ Advance Neonatal-Infant Nasal 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: K181624
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Complaint File Establishment
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