Healthdyne, Inc.

FDA 510(k) & PMA Approved Devices — 35 products

Total Devices35

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K950331	PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)	BZD	1995-09-21	View
510(k)	K922106	ALICE	OLV	1994-07-06	View
510(k)	K942357	H-500 ALLIANCE OXYGEN CONCENTRATOR	CAW	1994-05-27	View
510(k)	K934502	FLOW SPIROMETER	BZH	1994-04-04	View
510(k)	K924146	OH-500 OXYGEN CONCENTRATOR	CAW	1993-01-07	View
510(k)	K922623	NEBULIZER SYSTEM	BTI	1992-12-01	View
510(k)	K910118	DATA RECORDER	FLL	1991-02-14	View
510(k)	K903287	MODEL 900S APNEA/HEART MONITOR	BZQ	1990-08-17	View
510(k)	K894030	MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR	HFM	1990-01-22	View
510(k)	K892006	HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S	DRT	1989-05-23	View
510(k)	K890150	H-3000 OXYGEN CONCENTRATOR	CAW	1989-01-31	View
510(k)	K881833	NASAL CPAP SYSTEM	BYE	1988-06-24	View
510(k)	K875031	OXYGEN/PULSE MONITOR	DQA	1988-02-12	View
510(k)	K874814	HEALTHDYNE RATE METER	BZQ	1988-02-11	View
510(k)	K874695	HEALTHDYNE APNEA/HEART MONITOR, MODEL 900	DRT	1988-01-29	View
510(k)	K861484	INFANT MONITOR	BZQ	1986-05-21	View
510(k)	K860254	HEALTHDYNE'S EVENT RECORDER SYSTEM	BZQ	1986-01-30	View
510(k)	K854374	OXYGEN CONCENTRATOR, MODEL BX-5000	CAW	1986-01-03	View
510(k)	K853300	HEALTHDYNE IMPLUSE VENTILATOR	CBK	1985-08-15	View
510(k)	K843546	INFANT MONITOR 16900	BZQ	1984-10-10	View