Biophysical Monitoring System
FDA 510(k) K780425 · Gould, Inc.
510(k) numberK780425
Submission
- Device name
- Biophysical Monitoring System
- Applicant
- Gould, Inc.
Mchenry, IL, US - Received
- March 17, 1978
- Decision date
- April 28, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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|---|---|---|
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| 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 |
Questions and answers
When was Biophysical Monitoring System cleared by the FDA?
Biophysical Monitoring System (K780425) received a 510(k) decision of Substantially Equivalent on April 28, 1978, 42 days after the submission was received.
What is the product code of K780425?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.