Cardiac Electrophysical Lead Selector, Modified
FDA 510(k) K911935 · Gould, Inc.
510(k) numberK911935
Submission
- Device name
- Cardiac Electrophysical Lead Selector, Modified
- Applicant
- Gould, Inc.
Valley View, OH, US - Received
- May 1, 1991
- Decision date
- July 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRR – Amplifier And Signal Conditioner, Biopotential
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2050
- Specialty
- Cardiovascular
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| K971570 | Epxpress System (Timberwolf Revision) /000391DRR · Traditional | Quinton Electrophysiology Corp. | 12/29/1997SE |
| K925346 | Ep Amp, Model #901DRR · Traditional | Quinton Electrophysiology Corp. | 04/30/1993SE |
| K914381 | Horizon 9000/HIS Option AmplifierDRR · Traditional | Mennen Medical, Inc. | 01/28/1992SE |
| K910307 | Cardiolab Amplifier Module (Cam)DRR · Traditional | Prucka Engineering, Inc. | 04/12/1991SE |
| K894735 | ASC-952 Physiological AmplifierDRR · Traditional | Astro-Med, Inc. | 09/18/1989SE |
| K894161 | ASC-950 ECG AmplifierDRR · Traditional | Astro-Med, Inc. | 08/03/1989SE |
| K874441 | Bard Biopotential AmplifierDRR · Traditional | C.R. Bard, Inc. | 01/19/1988SE |
| K853652 | BERS-400A Electrophysiological Amplifiers & InputDRR · Traditional | Fisher Imaging Corp. | 01/16/1986SE |
| K813123 | Epc FilterDRR · Traditional | Codman & Shurtleff, Inc. | 11/27/1981SE |
More from Codman & Shurtleff, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861092 | Model SP1465 Cardiac Output ComputerDXG · Traditional | 08/18/1986SE |
| K860805 | Pressure Monitor Cath Models SP5325,SP5327,SP5337DQO · Traditional | 05/08/1986SE |
| K855145 | Model:Ta-Rose Resonant Overshoot EliminatorDRS · Traditional | 02/26/1986SE |
| K854403 | Model 2120 SpiroscreenBZG · Traditional | 01/14/1986SE |
| K851486 | Gould Disposable Transducer & Accessories-DtxDRS · Traditional | 10/17/1985SE |
| K850114 | C/Pes 9201, ECG Stress Testing SysDRT · Traditional | 02/22/1985SE |
| K850113 | C/Pes 9103, ECG Stress Testing SystemDRT · Traditional | 02/08/1985SE |
| K843555 | Cardiac Computer SP1445DXG · Traditional | 02/01/1985SE |
| K843969 | Model P23XL Physiological Pressure TransducerDXO · Traditional | 01/23/1985SE |
| K843970 | Model IM1074 End-Tidal CO2 ModuleCCK · Traditional | 10/24/1984SE |
Questions and answers
When was Cardiac Electrophysical Lead Selector, Modified cleared by the FDA?
Cardiac Electrophysical Lead Selector, Modified (K911935) received a 510(k) decision of Substantially Equivalent on July 22, 1991, 82 days after the submission was received.
What is the product code of K911935?
The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.