Diamond Medical, Inc. Model DM 600
FDA 510(k) K874710 · Diamond Medical, Inc.
510(k) numberK874710
Submission
- Device name
- Diamond Medical, Inc. Model DM 600
- Applicant
- Diamond Medical, Inc.
St. Paul, MN, US - Received
- November 12, 1987
- Decision date
- February 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K102543 | Bravo PH Monitoring System and AccessoriesFFT · Traditional | Given Imaging , Ltd. | 12/01/2010SE |
| 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 |
| K934434 | Cyberrx Model 7200FFT · Traditional | Cybermed Control Systems, Inc. | 01/24/1995SE |
| K925405 | Zinetics Composite Sensor Probe W/Internal Ref.FFT · Traditional | Synectics-Dantec | 09/30/1994SE |
More from Synectics-Dantec
| 510(k) | Device | Decision |
|---|---|---|
| K924758 | Dmi Blood Gas Analyzer/CartridgeCHL · Traditional | 12/03/1992SE |
| K915087 | Dmi Blod Gas Analyzer/CartridgeCHL · Traditional | 01/08/1992SE |
| K874709 | Diamond Medical, Inc. Model DM 800FFT · Traditional | 02/08/1988SE |
| K875369 | Model ISO-2001 Univ. Patient Isolation CircuitFFT · Traditional | 02/05/1988SE |
| K863298 | Diamond Medical, Inc., Model DM 700FFT · Traditional | 03/17/1987SE |
Questions and answers
When was Diamond Medical, Inc. Model DM 600 cleared by the FDA?
Diamond Medical, Inc. Model DM 600 (K874710) received a 510(k) decision of Substantially Equivalent on February 8, 1988, 88 days after the submission was received.
What is the product code of K874710?
The FDA product code is FFT – Electrode, Ph, Stomach, a Class I (low risk) device regulated under 21 CFR 876.1400.