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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803129231, Alligator Clips, AMMI; 989803166031, Clear Tab/Snap Adapter; 989803175891, 12-Lead Patient Cable (IEC), Standard Length; 989803175901, 12-Lead Patient Cable (AAMI), Standard Length; 989803175911, 12-Lead Patient Cable (IEC), Long; 989803175921, 12-Lead Patient Cable (AAMI), Long; PageWriter TC20; PageWriter TC20, TC30, TC50, TC70 w/PIM, Lead Sets, Adapters, Electrodes
Classification Name: ELECTROCARDIOGRAPH
Product Code: DPS
Device Class: 2
Regulation Number: 870.2340
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K113144
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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