Model 600 Vascular Duplex Imager
FDA 510(k) K863589 · Multigon Industries, Inc.
510(k) numberK863589
Submission
- Device name
- Model 600 Vascular Duplex Imager
- Applicant
- Multigon Industries, Inc.
Mt. Vernon, NY, US - Received
- September 15, 1986
- Decision date
- June 24, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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| K904978 | Software Program Used W/Prism ProductsDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
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More from Prism Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K052067 | Doppler Guided Proctoscope, Model 500HJAF · Traditional | 08/29/2005SE |
| K051739 | Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler…IYN · Traditional | 07/28/2005SE |
| K912044 | Model 700 Laparoscopic Electronic InsufflatorHIF · Traditional | 06/24/1991SE |
| K881263 | Model 500A Vascular Spectrum Analyzer W/DopplerHGL · Traditional | 01/05/1990SE |
| K882755 | Model 500V Vascular Spectrum AnalyzerIYN · Traditional | 11/29/1988SE |
| K860435 | Model 500A Vascular Spectrum Analyzer W/Cw DopplerDPT · Traditional | 05/05/1986SE |
| K852680 | Triton Laparoscopic Coagulator Insufflator & LavagHET · Traditional | 12/23/1985SE |
Questions and answers
When was Model 600 Vascular Duplex Imager cleared by the FDA?
Model 600 Vascular Duplex Imager (K863589) received a 510(k) decision of Substantially Equivalent on June 24, 1987, 282 days after the submission was received.
What is the product code of K863589?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.