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U.S. Department of Health and Human Services

Product Classification
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Device tempo pilot ckm: cardio-kidney-metabolic
Definition TEMPO Pilot: cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)
Physical State TEMPO Pilot: cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)
Technical Method Digital Health Device
Target Area TEMPO Pilot: cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)
Review Panel Clinical Chemistry
Product CodeSIC
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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