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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 21090A Esophageal/Rectal Temperature Probe 12FR; 21091A Skin Temperature Probe; 23001A Temperature Probe; 23001B Temperature Probe; 23002A Reusable Bath Temperature Probe; M1837A Esophageal/Rectal Temperature Probe 9FR
Classification Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Product Code: MHX
Device Class: 2
Regulation Number: 870.1025
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K033444
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Repackager/Relabeler
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