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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length; 989803151641, 12-Lead Complete Lead Set (IEC), Standard Length; 989803151651, 12-Lead Complete Lead Set (AAMI), Long; 989803151661, 12-Lead Complete Lead Set (IEC), Long; 989803151671, 12-Lead Chest Lead Set (AAMI/IEC), Standard Length; 989803151691, 12-Lead Chest Lead Set (AAMI/IEC), Long; 989803151711, 12-Lead Limb Lead Set (AAMI/IEC), Standard Length; 989803151731, 12-Lead Limb Lead Set (AAMI/IEC), Long; 989803151751, 15/16/18-Lead Upgrade Kit (AAMI), Standard Length; 989803151761, 15/16/18-Lead Upgrade Kit (IEC), Standard Length; 989803151771, 15/16/18-Lead Upgrade Kit (AAMI), Long; 989803151781, 15/16/18-Lead Upgrade Kit (IEC), Long; 989803164281, USB Patient Data Cable, Class B
Classification Name: ELECTROCARDIOGRAPH
Product Code: DPS
Device Class: 2
Regulation Number: 870.2340
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K080999
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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