Company ยท US
Gould, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1991. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | 6 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 4 |
| KRB | Probe, Thermodilution | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| DYG | Catheter, Flow Directed | 2 |
| BZG | Spirometer, Diagnostic | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| DXO | Transducer, Pressure, Catheter Tip | 1 |
| DYB | Introducer, Catheter | 1 |
| KRA | Catheter, Continuous Flush | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 1991 | K911935 | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED Gould, Inc. | DRR |
| Aug 18, 1986 | K861092 | MODEL SP1465 CARDIAC OUTPUT COMPUTER Gould, Inc. | DXG |
| May 8, 1986 | K860805 | PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 Gould, Inc. | DQO |
| Feb 26, 1986 | K855145 | MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR Gould, Inc. | DRS |
| Jan 14, 1986 | K854403 | MODEL 2120 SPIROSCREEN Gould, Inc. | BZG |
| Oct 17, 1985 | K851486 | GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX Gould, Inc. | DRS |
| Feb 22, 1985 | K850114 | C/PES 9201, ECG STRESS TESTING SYS Gould, Inc. | DRT |
| Feb 8, 1985 | K850113 | C/PES 9103, ECG STRESS TESTING SYSTEM Gould, Inc. | DRT |
| Feb 1, 1985 | K843555 | CARDIAC COMPUTER SP1445 Gould, Inc. | DXG |
| Jan 23, 1985 | K843969 | MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER Gould, Inc. | DXO |
| Oct 24, 1984 | K843970 | MODEL IM1074 END-TIDAL CO2 MODULE Gould, Inc. | CCK |
| Jun 15, 1984 | K840909 | AUTOMATED NON-INVASIVE PRESSURE MODULE Gould, Inc. | DXN |
| May 23, 1984 | K840992 | THERMODILUTION CATHETER Gould, Inc. | KRB |
| May 23, 1984 | K840824 | HEPARIN COATED THERMODILUTION CATHETERS Gould, Inc. | KRB |
| Jun 22, 1983 | K830885 | GOULD MODEL IM3000-IM3100 BATTERY POWER Gould, Inc. | DRT |
| Mar 16, 1983 | K830523 | CATHETER CONNECTION W/INTEGRAL INJECTATE Gould, Inc. | DQO |
| Jan 18, 1983 | K823262 | MODEL SP5800 #8 FRENCH INTRO. KIT Gould, Inc. | DYB |
| Sep 14, 1982 | K822507 | DISPOSABLE TRANSDUCER & ACCESSORIES Gould, Inc. | DRS |
| May 25, 1982 | K821450 | PRESSURE TUBING-ADULT & PEDIATRIC Gould, Inc. | DRS |
| May 18, 1982 | K821235 | HEPARIN COATED THERMODILUTION CATHETER Gould, Inc. | DYG |
| Jun 18, 1981 | K811537 | MODEL SP 5507 5-LUMEN THERMODILUTION CAT Gould, Inc. | KRB |
| Jun 12, 1981 | K811538 | MODELS TA 1017 & 1017T GRITIFLO DISPOS Gould, Inc. | DRS |
| Mar 27, 1981 | K810731 | MODEL IM1000 INTEGRATED MONITOR Gould, Inc. | DQK |
| Mar 27, 1981 | K810730 | MODEL SP5107 THERMODILUTION CATHETER Gould, Inc. | KRB |
| Nov 19, 1980 | K802476 | CARDIACINDEX COMPUTER MODEL SP 1435 Gould, Inc. | DXG |
| Oct 2, 1979 | K791844 | CRITIFLO & CRITIFLO DOME Gould, Inc. | KRA |
| Jun 13, 1978 | K780798 | GOULD-STATHAM SP1405 PRESSURE MONITOR Gould, Inc. | DSK |
| Jun 13, 1978 | K780797 | TRANSDUCER, PRESSURE, OPTION, H-P, P23ID Gould, Inc. | DRS |
| Apr 28, 1978 | K780425 | BIOPHYSICAL MONITORING SYSTEM Gould, Inc. | DXJ |
| Sep 9, 1976 | K760533 | CATHETER, FLOW DIRECTED THERMAL DILUTION Gould, Inc. | DYG |
| Sep 9, 1976 | K760532 | COMPUTER, CARDIAC OUTPUT (#SP1425) Gould, Inc. | DXG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||