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U.S. Department of Health and Human Services

Product Classification

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Device monitor, electric for gravity flow infusion systems
Regulation Description Electronic monitor for gravity flow infusion systems.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFLN
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.2420
Device Class 2
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
Accredited Persons
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