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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; MX40
Classification Name: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
Product Code: DRT
Device Class: 2
Regulation Number: 870.2300
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K180017
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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