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U.S. Department of Health and Human Services

Product Classification

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Device injector, contrast medium, automatic, reprocessed
Regulation Description Angiographic injector and syringe.
Regulation Medical Specialty Cardiovascular
Review Panel General Hospital
Product CodeNKP
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 870.1650
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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