Cyberrx Model 7200
FDA 510(k) K934434 · Cybermed Control Systems, Inc.
510(k) numberK934434
Submission
- Device name
- Cyberrx Model 7200
- Applicant
- Cybermed Control Systems, Inc.
San Diego, CA, US - Received
- August 23, 1993
- Decision date
- January 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFT – Electrode, Ph, Stomach
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1400
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
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| K013951 | Sandhill Scientific Pediatec PH ProbeFFT · Traditional | Sandhill Scientific, Inc. | 02/28/2002SE |
| K002028 | Bravo PH Monitoring SystemFFT · Traditional | Endonetics, Inc. | 09/29/2000SE |
| K961346 | PH Analysis ModuleFFT · Traditional | Synectics-Dantec | 01/29/1997SE |
| K950087 | Lot 440FFT · Traditional | Medical Instruments Corporation Mic AG | 02/06/1996SE |
| K955018 | Trip NGS & Sigmoid Catheter Phi Slide CalculatorFFT · Traditional | Instrumentarium Corp. | 01/30/1996SE |
| K945069 | Flexilog 2000FFT · Traditional | Oakfield Instruments, Ltd. | 06/13/1995SE |
| K920849 | Trip Cic CatheterFFT · Traditional | Tonometrics, Inc. | 03/17/1995SE |
| K925405 | Zinetics Composite Sensor Probe W/Internal Ref.FFT · Traditional | Synectics-Dantec | 09/30/1994SE |
| K931963 | Sandhill Disposable Internal Reference PH ProbeFFT · Traditional | Sandhill Scientific, Inc. | 09/28/1994SE |
Questions and answers
When was Cyberrx Model 7200 cleared by the FDA?
Cyberrx Model 7200 (K934434) received a 510(k) decision of Substantially Equivalent on January 24, 1995, 519 days after the submission was received.
What is the product code of K934434?
The FDA product code is FFT – Electrode, Ph, Stomach, a Class I (low risk) device regulated under 21 CFR 876.1400.