| Proprietary Name: |
Expression MR ECG Leads, AAMI - 989803193721; Expression MR ECG Leads, AAMI, Neonatal - 989803193741; Expression MR ECG Leads, AAMI, Standard - 989803193731; Expression MR ECG Leads, IEC, CV - 989803193751; Expression MR ECG Leads, IEC, Neonatal - 989803193771; Expression MR ECG Leads, IEC, Standard - 989803193761; Expression MR FlexTEMP II Sensor - 989803194511; Expression MR IBP Transducer Cable, 5ft - 989803194601; Expression MR Universal Gating Interface - 989803195521; Expression MR Wireless ECG Patient Module (Gen 3) 1-5 - 989803192761; Expression MR Wireless ECG Patient Module (Gen 3) 6-10 - 989803194341; Expression MR Wireless SPO2 Patient module (Gen 3) 1-5 - 989803192771; Expression MR Wireless SpO2 Patient Module (Gen 3)6-10 - 989803194331; Expression MR400 MRI Patient Monitoring System (Model MR400); Expression MR400 New MRI Monitor Accessories - 866428; FlexTEMP System, Sensor - 989803178171 |
| Classification Name: |
MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) |
| Product Code: |
MWI |
| Device Class: |
2 |
| Regulation Number: |
870.2300 |
| Medical Specialty: |
Cardiovascular |
| Registered Establishment Name: |
Philips Electronics Ltd
|
| Registered Establishment Number: |
3000126629
|
| Premarket Submission Number: |
K152330 |
| Owner/Operator: |
Philips Medical Systems International BV |
| Owner/Operator Number: |
1217116
|
| Establishment Operations: |
Foreign Exporter
|
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