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U.S. Department of Health and Human Services

Product Classification
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Device monitor, lung water measurement
Regulation Description Lung water monitor.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeJEZ
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type PMA
Regulation Number 868.2450
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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