Smartdop XT
FDA 510(k) K131623 · Koven Technology, Inc.
510(k) numberK131623
Submission
- Device name
- Smartdop XT
- Applicant
- Koven Technology, Inc.
Houston, TX, US - Received
- June 4, 2013
- Decision date
- January 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOP – Transducer, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2880
- Specialty
- Cardiovascular
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|---|---|---|---|
| K242662 | Falcon/Xpress (Falcon/Xpress)JOP · Traditional | Viasonix , Ltd. | 12/18/2024SE |
| K233976 | VasoGuard (V10, V8, V6, V4, V2)JOP · Traditional | Corvascular Diagnostics, LLC | 07/19/2024SE |
| K153762 | Smartdop XT6JOP · Traditional | Koven Technology, Inc. | 05/25/2016SE |
| K131860 | Vasculab VL4000 Photoplethysmograph with Pulse Volume RecordingJOP · Traditional | Us Vascular, LLC | 09/27/2013SE |
| K111416 | FalconJOP · Traditional | Viasonix , Ltd. | 07/15/2011SE |
| K071730 | Studiodop VicorderJOP · Abbreviated | Skidmore Medical, Limited | 12/20/2007SE |
| K010482 | Echoflow Portable Doppler Blood Flow Measurement System; Model PEF-1JOP · Special | Echocath, Inc. | 03/20/2001SE |
| K002766 | Nicolet VasoguardJOP · Abbreviated | Nicolet Biomedical | 11/30/2000SE |
| K990642 | Echoflow Doppler Blood Velocity MeterJOP · Traditional | Echocath, Inc. | 09/16/1999SE |
| K925078 | SpectradopJOP · Traditional | Bennett and Assoc., Inc. | 07/17/1995SE |
More from Bennett and Assoc., 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 |
| K080178 | Valvulotome by KovenMGZ · Traditional | 07/28/2008SE |
| K050601 | Smartdop 45 Vascular DopplerDPW · Traditional | 04/15/2005SE |
| 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 XT cleared by the FDA?
Smartdop XT (K131623) received a 510(k) decision of Substantially Equivalent on January 17, 2014, 227 days after the submission was received.
What is the product code of K131623?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.