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U.S. Department of Health and Human Services

Product Classification
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Device system, telethermographic (sole diagnostic screen)
Regulation Description Telethermographic system.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Radiology
Product CodeLHP
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type PMA
Regulation Number 884.2980
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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