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U.S. Department of Health and Human Services

Product Classification
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Device device, temperature measurement, direct contact, powered
Regulation Description Powered direct-contact temperature measurement device.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHCS
Submission Type 510(k)
Regulation Number 882.1570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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