Smartdop 45 Vascular Doppler
FDA 510(k) K050601 · Koven Technology, Inc.
510(k) numberK050601
Submission
- Device name
- Smartdop 45 Vascular Doppler
- Applicant
- Koven Technology, Inc.
Houston, TX, US - Received
- March 9, 2005
- Decision date
- April 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| K223843 | FloPatch FP120DPW · Traditional | Flosonics Medical | 05/03/2023SE |
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| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
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More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201114 | Bidop 7DPW · Traditional | 01/05/2021SE |
| K153762 | Smartdop XT6JOP · Traditional | 05/25/2016SE |
| K143332 | Fast Sphyg by KovenDXQ · Traditional | 04/14/2015SE |
| K131623 | Smartdop XTJOP · Traditional | 01/17/2014SE |
| K080178 | Valvulotome by KovenMGZ · Traditional | 07/28/2008SE |
| K031931 | Echo Sounder EX-101EX 8 MHZDPW · Traditional | 02/13/2004SE |
| K031504 | Echo Sounder, Single-Handed, Model ES-101EXKNG · Traditional | 07/18/2003SE |
| K023143 | Echo Sounder, ES-102EXKNG · Traditional | 12/19/2002SE |
| K010452 | Bi-Directional Doppler Volume Flowmeter, Model DVM-4300 & 4300TDPW · Traditional | 02/12/2002SE |
| K982986 | Tubing Blood Flow Meter Model Number HD-800DPW · Traditional | 11/24/1998SE |
Questions and answers
When was Smartdop 45 Vascular Doppler cleared by the FDA?
Smartdop 45 Vascular Doppler (K050601) received a 510(k) decision of Substantially Equivalent on April 15, 2005, 37 days after the submission was received.
What is the product code of K050601?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.