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FJB

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Detector, Dialysate Level
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
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RecordFirmDate
ACCUFLO UF CONTROL MODULE NO. 74-0100-3 (K883490)National Medical Care, Medical Products Div., Inc.1988-09-29
CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 (K881062)Cobe Laboratories, Inc.1988-04-21
UFR DIGITAL RETROFIT (K875312)Yankee Intl. Medical Research & Mfg., Ltd.1988-02-19

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