Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler Ultraound Probe, Model 2MPB.
FDA 510(k) K051739 · Multigon Industries, Inc.
510(k) numberK051739
Submission
- Device name
- Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler Ultraound Probe, Model 2MPB.
- Applicant
- Multigon Industries, Inc.
Yonkers, NY, US - Received
- June 28, 2005
- Decision date
- July 28, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
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| K882755 | Model 500V Vascular Spectrum AnalyzerIYN · Traditional | 11/29/1988SE |
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| K860435 | Model 500A Vascular Spectrum Analyzer W/Cw DopplerDPT · Traditional | 05/05/1986SE |
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Questions and answers
When was Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler Ultraound Probe, Model 2MPB. cleared by the FDA?
Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler Ultraound Probe, Model 2MPB. (K051739) received a 510(k) decision of Substantially Equivalent on July 28, 2005, 30 days after the submission was received.
What is the product code of K051739?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.