Establishment Registration & Device Listing

Proprietary Name:	989803167541 Neonatal Single-Patient NIBP Cuffs; 989803167551 Neonatal Soft Single-Patient NIBP Cuffs; M1866B Neonatal Single-Patient Cuff Size #1; M1866S Neonatal Soft Single-Patient Cuff Size#1; M1868B Neonatal Single-Patient Cuff Size #2; M1868S Neonatal Soft Single-Patient Cuff Size#2; M1870B Neonatal Single-Patient Cuff Size #3; M1870S Neonatal Soft Single-Patient Cuff Size#3; M1872B Neonatal Single-Patient Cuff Size #4; M1872S Neonatal Soft Single-Patient Cuff Size#4; M1873B Infant Single-Patient Cuff Size #5; M1873S Infant Soft Single-Patient Cuff Size #5
Classification Name:	BLOOD PRESSURE CUFF
Product Code:	DXQ
Device Class:	2
Regulation Number:	870.1120
Medical Specialty:	Cardiovascular
Registered Establishment Name:	Philips North America LLC
Registered Establishment Number:	1218950
Premarket Submission Number:	K905101
Owner/Operator:	Philips Medical Systems International BV
Owner/Operator Number:	1217116
Establishment Operations:	Specification Developer