Vasoscan
FDA 510(k) K833902 · Sonicaid, Inc.
510(k) numberK833902
Submission
- Device name
- Vasoscan
- Applicant
- Sonicaid, Inc.
Mchenry, IL, US - Received
- November 14, 1983
- Decision date
- January 27, 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 |
|---|---|---|
| K873673 | BV105 (&BV105R) Vascular Flow Detector W/OptionalDPT · Traditional | 02/26/1988SE |
| K872074 | 5 MHZ TransducerJOP · Traditional | 08/25/1987SE |
| K863803 | Vasopulse(Tm)/Model 5000JOM · Traditional | 05/06/1987SE |
| K862720 | VASOFLO-3 & Extravascular Blood Flow ProbesDPW · Traditional | 11/17/1986SE |
| K861237 | Vasoview Duplex Imaging SystemITX · Traditional | 07/14/1986SN |
| K851102 | Vasoscreen Impedance PlethysmographDQB · Traditional | 05/16/1985SE |
| K832374 | Photoflo Dual-Mode PhotoplethysmographJOM · Traditional | 12/01/1983SE |
| K833488 | SonicompHEM · Traditional | 11/28/1983SE |
| K833227 | Sonicaid Model D206E Air Emboli-DetectLBA · Traditional | 10/27/1983SE |
| K831371 | Model FM5HGM · Traditional | 06/30/1983SE |
Questions and answers
When was Vasoscan cleared by the FDA?
Vasoscan (K833902) received a 510(k) decision of Substantially Equivalent on January 27, 1984, 74 days after the submission was received.
What is the product code of K833902?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.