Reusable CW Doppler Probes: Models P8M05S8A, P8M05N5A, & LCW-8
FDA 510(k) K934638 · Koven Technology, Inc.
510(k) numberK934638
Submission
- Device name
- Reusable CW Doppler Probes: Models P8M05S8A, P8M05N5A, & LCW-8
- Applicant
- Koven Technology, Inc.
St. Louis, MO, US - Received
- September 24, 1993
- Decision date
- May 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JOP – Transducer, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2880
- Specialty
- Cardiovascular
Other 510(k)s with product code JOP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K131623 | Smartdop XTJOP · Traditional | Koven Technology, Inc. | 01/17/2014SE |
| 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 |
More from Echocath, 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 |
| 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 |
Questions and answers
When was Reusable CW Doppler Probes: Models P8M05S8A, P8M05N5A, & LCW-8 cleared by the FDA?
Reusable CW Doppler Probes: Models P8M05S8A, P8M05N5A, & LCW-8 (K934638) received a 510(k) decision of Substantially Equivalent on May 13, 1994, 231 days after the submission was received.
What is the product code of K934638?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.