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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Advanced Apps ECG Cable - 989803176381; Expression IP5 Information Portal; Expression IP5 Software Upgrade - 989803197491; Expression MR Wireless ECG Patient Module - 989803183661; Expression MR200 MRI Patient Monitoring System; Expression MR200 New MRI Monitor Accessories - 866177; NiBP Cuff, Single Lumen, Adult - 989803182641; NiBP Cuff, Single Lumen, Adult, Disp - 989803182541; NiBP Cuff, Single Lumen, Adult-L - 989803182651; NiBP Cuff, Single Lumen, Adult-L, Disp - 989803182551; NiBP Cuff, Single Lumen, Infant #5, Disp - 989803183211; NiBP Cuff, Single Lumen, Infant - 989803182611; NiBP Cuff, Single Lumen, Infant, Disp - 989803182511; NiBP Cuff, Single Lumen, Lrg Adult - 989803182661; NiBP Cuff, Single Lumen, Lrg Adult, Disp - 989803182561; NiBP Cuff, Single Lumen, Lrg Adult-L - 989803182671; NiBP Cuff, Single Lumen, Neo #1, Disp - 989803183171; NiBP Cuff, Single Lumen, Neo #2, Disp - 989803183181; NiBP Cuff, Single Lumen, Neo #3, Disp - 989803183191; NiBP Cuff, Single Lumen, Neo #4, Disp - 989803183201; NiBP Cuff, Single Lumen, Pediatric - 989803182621; NiBP Cuff, Single Lumen, Pediatric, Disp - 989803182521; NiBP Cuff, Single Lumen, Sample Kit,Disp - 989803182591; NiBP Cuff, Single Lumen, Small Adult - 989803182631; NiBP Cuff, Single Lumen, Small Adult, Disp - 989803182531; NiBP Cuff, Single Lumen, Thigh - 989803182681; NiBP Cuff, Single Lumen, Thigh, Disp - 989803182581; NiBP Cuff, Single Lumen,Lrg Adult-L,Disp - 989803182571; Wireless SpO2 Patient Module - 989803183541
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: K131382
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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