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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803180121, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Grabber; 989803180131, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Grabber; 989803180141, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps; 989803180151, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Snaps; ST80i Stress Test System; ST80i Stress Test System w/ Printer, Lead Sets, Electrodes
Classification Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Product Code: DQK
Device Class: 2
Regulation Number: 870.1425
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K121638
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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