Medical Device Manufacturer · US , Mchenry , IL

Gould, Inc.

31 submissions · 31 cleared · Since 1976

31

Total

31

Cleared

0

Denied

Gould, Inc. — FDA 510(k) Submissions

Gould, Inc. has submitted 31 FDA 510(k) premarket notifications since 1976, of which 31 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Transducer, Blood-pressure, Extravascular, Probe, Thermodilution, Computer, Diagnostic, Pre-programmed, Single-function, Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm), Catheter, Intravascular, Diagnostic . Use the specialty filter in the sidebar to narrow results.

31 devices

1–12 of 31

CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED

K911935 · DRR Amplifier And Signal Conditioner, Biopotential · Cardiovascular

MODEL SP1465 CARDIAC OUTPUT COMPUTER

K861092 · DXG Computer, Diagnostic, Pre-programmed, Single-function · Cardiovascular

PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337

K860805 · DQO Catheter, Intravascular, Diagnostic · Cardiovascular

MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR

K855145 · DRS Transducer, Blood-pressure, Extravascular · Cardiovascular

MODEL 2120 SPIROSCREEN

K854403 · BZG Spirometer, Diagnostic · Anesthesiology

GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

K851486 · DRS Transducer, Blood-pressure, Extravascular · Cardiovascular

C/PES 9201, ECG STRESS TESTING SYS

K850114 · DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · Cardiovascular

C/PES 9103, ECG STRESS TESTING SYSTEM

K850113 · DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · Cardiovascular

CARDIAC COMPUTER SP1445

K843555 · DXG Computer, Diagnostic, Pre-programmed, Single-function · Cardiovascular

MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER

K843969 · DXO Transducer, Pressure, Catheter Tip · Cardiovascular

MODEL IM1074 END-TIDAL CO2 MODULE

K843970 · CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase · Anesthesiology

AUTOMATED NON-INVASIVE PRESSURE MODULE

K840909 · DXN System, Measurement, Blood-pressure, Non-invasive · Cardiovascular