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Edan Instruments, Inc.

FDA 510(k) & PMA Approved Devices — 50 products

Total Devices50

Categories13

Latest FDA decision2026-08-06

Type	Number	Device Name	Code	Date	Actions
510(k)	K162055	Acclarix LX8 Diagnostic Ultrasound System	IYN	2017-01-31	View
510(k)	K160981	Patient Monitor	MHX	2016-12-22	View
510(k)	K151978	EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control	CHL	2016-07-15	View
510(k)	K161302	PC ECG	DPS	2016-07-01	View
510(k)	K161300	Acclarix AX8 Diagnostic Ultrasound System	IYO	2016-05-31	View
510(k)	K152552	Patient Monitor	MHX	2016-04-29	View
510(k)	K160790	Acclarix LX8 Diagnostic Ultrasound System	IYN	2016-04-04	View
510(k)	K152427	PC ECG	DPS	2016-02-05	View
510(k)	K153475	SD5 & SD6 Ultrasonic Tabletop Doppler	KNG	2016-01-29	View
510(k)	K151787	Holter System	DQK	2016-01-27	View

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