Echoflow Doppler Blood Velocity Meter
FDA 510(k) K990642 · Echocath, Inc.
510(k) numberK990642
Submission
- Device name
- Echoflow Doppler Blood Velocity Meter
- Applicant
- Echocath, Inc.
Monmouth Junction, NJ, US - Received
- February 26, 1999
- Decision date
- September 16, 1999
- 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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| 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 |
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| 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 |
| K925078 | SpectradopJOP · Traditional | Bennett and Assoc., Inc. | 07/17/1995SE |
More from Bennett and Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010482 | Echoflow Portable Doppler Blood Flow Measurement System; Model PEF-1JOP · Special | 03/20/2001SE |
| K932436 | Echomark Intrauterine Guiding CatheterMOV · Traditional | 11/16/1995SE |
| K933417 | Echomark(R) Electrophysiology CatheterDRF · Traditional | 05/04/1995SE |
| K926351 | Colormark(Tm) Visualization SystemIYN · Traditional | 09/16/1993SE |
| K922787 | Echomark Guidewire with Ultrasonic LocalizationDQX · Traditional | 01/06/1993SE |
Questions and answers
When was Echoflow Doppler Blood Velocity Meter cleared by the FDA?
Echoflow Doppler Blood Velocity Meter (K990642) received a 510(k) decision of Substantially Equivalent on September 16, 1999, 202 days after the submission was received.
What is the product code of K990642?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.