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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803183311 Multi Care Cuff, Infant; 989803183321 Multi Care Cuff, Pediatric; 989803183331 Multi Care Cuff, Small Adult; 989803183341 Multi Care Cuff, Adult; 989803183351 Multi Care Cuff, Adult XL; 989803183361Multi Care Cuff, Large Adult; 989803183371 Multi Care Cuff, Thigh; M1571A Comfort Care Cuff, Infant; M1572A Comfort Care Cuff, Pediatric; M1573A Comfort Care Cuff, Small Adult; M1574A Comfort Care Cuff, Adult; M1574XL Comfort Care Cuff, Adult XL; M1575A Comfort Care Cuff, Large Adult; M1576A Comfort Care Cuff, Thigh
Classification Name: DETECTOR AND ALARM, ARRHYTHMIA
Product Code: DSI
Device Class: 2
Regulation Number: 870.1025
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K001333
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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