Vascular Recorder #301
FDA 510(k) K832369 · Imex Medical Systems, Inc.
510(k) numberK832369
Submission
- Device name
- Vascular Recorder #301
- Applicant
- Imex Medical Systems, Inc.
Mchenry, IL, US - Received
- July 15, 1983
- Decision date
- March 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K973556 | Imex Medical Systems, Inc. Imexlab 9000IYN · Traditional | 04/24/1998SE |
| K973562 | Imex Medical Systems, Inc. Imexlab 9100IYN · Traditional | 04/15/1998SE |
| K973336 | Imex StethodopJAF · Traditional | 02/05/1998SE |
| K970156 | Imex Futuraldop ProIYO · Traditional | 04/04/1997SE |
| K942243 | Imex 8000 Personal Cascular LabIYO · Traditional | 11/03/1995SE |
| K944196 | Imwxdop IrJAF · Traditional | 05/12/1995SE |
| K942441 | Imexdop Ct+JAF · Traditional | 08/23/1994SE |
| K910462 | Pocket Dop 3HEP · Traditional | 06/24/1991SE |
| K901593 | Imex Dop-Tone IIKNG · Traditional | 07/02/1990SE |
| K896613 | Flat Vascular ProbeDPW · Traditional | 02/16/1990SE |
Questions and answers
When was Vascular Recorder #301 cleared by the FDA?
Vascular Recorder #301 (K832369) received a 510(k) decision of Substantially Equivalent on March 12, 1984, 241 days after the submission was received.
What is the product code of K832369?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.