Establishment Registration & Device Listing

Proprietary Name:	989803157481, DigiTrak XT Patient Cable, short; 989803157491, DigiTrak XT Patient Cable, Medium; 989803157501, DigiTrak XT Patient Cable, Long; BTP-1000A-Hybrid Patch; BTP-1000L-2-Lead Wire Adapter; CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171; CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161; CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181; EEG Leadset - 989803180521; EEG Leadset - 989803180531; EEG Leadset - 989803180541; EEG Leadset - 989803180561; Flex Adapter; Lead Wire Adapter; M1532A ECG Cable; M1533A ECG Cable; M1602A ECG Cable; M1624A ECG Cable; M1626A ECG Cable; M1644A ECG Cable; M1645A ECG Cable; M1663A ECG Trunk Cable; M1665A ECG Trunk Cable; M1667A ECG Trunk Cable; M1668A ECG Trunk Cable; M1669A ECG Trunk Cable; M1671A ECG Cable; M1672A ECG Cable; M1673A ECG Cable; M1674A ECG Cable; M1675A ECG Cable; M1678A ECG Cable; M1680A ECG Cable; M1681A ECG Cable; M1934A EEG Leadset; M1949A ECG Trunk Cable; M1968A ECG Cable; M1971A ECG Cable; M1973A ECG Cable; M1974A ECG Cable; M1976A ECG Cable; M1978A ECG Cable; M1979A ECG Cable; M2268A EEG Trunk Cable; OMNI-TRAK 3000 SERIES
Classification Name:	CABLE, ELECTRODE
Product Code:	IKD
Device Class:	2
Regulation Number:	890.1175
Medical Specialty:	Physical Medicine
Registered Establishment Name:	Philips North America LLC
Registered Establishment Number:	1218950
Owner/Operator:	Philips Medical Systems International BV
Owner/Operator Number:	1217116
Establishment Operations:	Specification Developer