Gould, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDJuly 22, 1991
K861092MODEL SP1465 CARDIAC OUTPUT COMPUTERAugust 18, 1986
K860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337May 8, 1986
K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORFebruary 26, 1986
K854403MODEL 2120 SPIROSCREENJanuary 14, 1986
K851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTXOctober 17, 1985
K850114C/PES 9201, ECG STRESS TESTING SYSFebruary 22, 1985
K850113C/PES 9103, ECG STRESS TESTING SYSTEMFebruary 8, 1985
K843555CARDIAC COMPUTER SP1445February 1, 1985
K843969MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCERJanuary 23, 1985
K843970MODEL IM1074 END-TIDAL CO2 MODULEOctober 24, 1984
K840909AUTOMATED NON-INVASIVE PRESSURE MODULEJune 15, 1984
K840992THERMODILUTION CATHETERMay 23, 1984
K840824HEPARIN COATED THERMODILUTION CATHETERSMay 23, 1984
K830885GOULD MODEL IM3000-IM3100 BATTERY POWERJune 22, 1983
K830523CATHETER CONNECTION W/INTEGRAL INJECTATEMarch 16, 1983
K823262MODEL SP5800 #8 FRENCH INTRO. KITJanuary 18, 1983
K822507DISPOSABLE TRANSDUCER & ACCESSORIESSeptember 14, 1982
K821450PRESSURE TUBING-ADULT & PEDIATRICMay 25, 1982
K821235HEPARIN COATED THERMODILUTION CATHETERMay 18, 1982