Nicolet Vasoguard
FDA 510(k) K002766 · Nicolet Biomedical
510(k) numberK002766
Submission
- Device name
- Nicolet Vasoguard
- Applicant
- Nicolet Biomedical
Golden, CO, US - Received
- September 5, 2000
- Decision date
- November 30, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
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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 |
| 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 |
| 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 |
|---|---|---|
| K020754 | Nicolet Pioneer TC8080IYN · Abbreviated | 04/21/2003SE |
| K021986 | BrainetGXY · Traditional | 08/23/2002SE |
| K021144 | Subdural Strip ElectrodeGYC · Abbreviated | 06/24/2002SE |
| K020218 | Snap EEG MonitorOLW · Abbreviated | 04/22/2002SE |
| K013281 | Versalab ApmHGM · Abbreviated | 04/18/2002SE |
| K020955 | Nicolet Electrocautery DetectorETN · Abbreviated | 04/17/2002SE |
| K013419 | Nicolet Electromagnetic Navigation SystemLLZ · Traditional | 12/20/2001SE |
| K011823 | Biorehab SystemHCC · Abbreviated | 09/06/2001SE |
| K011818 | Sterile Emg ElectrodesIKT · Abbreviated | 09/06/2001SE |
| K011135 | Gsi AuderaEWO · Traditional | 07/26/2001SE |
Questions and answers
When was Nicolet Vasoguard cleared by the FDA?
Nicolet Vasoguard (K002766) received a 510(k) decision of Substantially Equivalent on November 30, 2000, 86 days after the submission was received.
What is the product code of K002766?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.