FDA Registration Active 🇨🇦 Canada

Sampling Line Male Luer-lok Adapter Dehumidification

Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
Products
10
Proprietary Names
15
Establishment Types
1
Classifications
10

Registration Details

Registration Name
Philips Electronics Ltd
Registration Number
3000126629
FEI Number
3000126629
Status
Active
Expiry Year
2025
Initial Importer
No
Address
1875 Buckhorn Gate, 5th Floor
City
Mississauga Ontario
Country
CA

Regulatory Submissions

510(k) Number
K083750

Owner / Operator

Firm Name
Philips Medical Systems International BV
Operator Number
1217116
Address
Veenpluis 6
City
Best
State
NL-NOTA
Postal Code
5684PC
Country
NL

US Agent

Business Name
Philips
Contact Name
Shaylee Masilunas
Address
6501 Living Place
City
Pittsburgh
State
PA
ZIP
15206
Country
US
Phone
724 8162019

Products

Device Name Product Code
Plethysmograph, Impedance DSB
Detector And Alarm, Arrhythmia DSI
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
Computer, Diagnostic, Programmable DQK
System, Measurement, Blood-Pressure, Non-Invasive DXN
Oximeter DQA
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
Full-Montage Standard Electroencephalograph GWQ
Electrocardiograph DPS

Proprietary Names

Sampling Line Male Luer-lok Adapter Dehumidification Airway Adapter Pediatric/Infant Nafion Capnoflex Airway Adapter Adult/Pediatric Capnoflex Cannula Nasal CO2 Only Pediatric Capnoflex Cannula Nasal CO2 Adult Capnoflex Infant/Neonatal Airway Adapter Kit Capnoflex Pediatric Nasal/Oral CO2 Cannula Capnoflex Pediatric Nasal CO2/O2 Cannula Capnoflex Sample Line Male Luer Capnoflex Airway Adapter Adult/Pediatric Nafion Capnoflex Adult Nasal/Oral CO2 Cannula Capnoflex Infant Nasal CO2 Cannula Capnoflex Infant Nasal CO2/O2 Cannula Cannula Oral/Nasal CO2/O2 Adult Capnoflex D Cannula Nasal CO2/O2 Adult Capnoflex

Establishment Types

Export Device to the United States But Perform No Other Operation on Device