Gould, Inc.

FDA 510(k) & PMA Approved Devices — 31 products

Total Devices31

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K911935	CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED	DRR	1991-07-22	View
510(k)	K861092	MODEL SP1465 CARDIAC OUTPUT COMPUTER	DXG	1986-08-18	View
510(k)	K860805	PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337	DQO	1986-05-08	View
510(k)	K855145	MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR	DRS	1986-02-26	View
510(k)	K854403	MODEL 2120 SPIROSCREEN	BZG	1986-01-14	View
510(k)	K851486	GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX	DRS	1985-10-17	View
510(k)	K850114	C/PES 9201, ECG STRESS TESTING SYS	DRT	1985-02-22	View
510(k)	K850113	C/PES 9103, ECG STRESS TESTING SYSTEM	DRT	1985-02-08	View
510(k)	K843555	CARDIAC COMPUTER SP1445	DXG	1985-02-01	View
510(k)	K843969	MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER	DXO	1985-01-23	View
510(k)	K843970	MODEL IM1074 END-TIDAL CO2 MODULE	CCK	1984-10-24	View
510(k)	K840909	AUTOMATED NON-INVASIVE PRESSURE MODULE	DXN	1984-06-15	View
510(k)	K840824	HEPARIN COATED THERMODILUTION CATHETERS	KRB	1984-05-23	View
510(k)	K840992	THERMODILUTION CATHETER	KRB	1984-05-23	View
510(k)	K830885	GOULD MODEL IM3000-IM3100 BATTERY POWER	DRT	1983-06-22	View
510(k)	K830523	CATHETER CONNECTION W/INTEGRAL INJECTATE	DQO	1983-03-16	View
510(k)	K823262	MODEL SP5800 #8 FRENCH INTRO. KIT	DYB	1983-01-18	View
510(k)	K822507	DISPOSABLE TRANSDUCER & ACCESSORIES	DRS	1982-09-14	View
510(k)	K821450	PRESSURE TUBING-ADULT & PEDIATRIC	DRS	1982-05-25	View
510(k)	K821235	HEPARIN COATED THERMODILUTION CATHETER	DYG	1982-05-18	View