Cardioscan with Doppler Option
FDA 510(k) K862913 · Interspec, Inc.
510(k) numberK862913
Submission
- Device name
- Cardioscan with Doppler Option
- Applicant
- Interspec, Inc.
Conshohocken, PA, US - Received
- August 1, 1986
- Decision date
- November 4, 1986
- 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
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|---|---|---|---|
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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 |
| 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 |
|---|---|---|
| K940671 | Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound FlowmeterITX · Traditional | 11/22/1994SE |
| K924231 | Interspec Apogee ClaIYO · Traditional | 06/14/1993SE |
| K915696 | Interspec Apogee Endo-V Probe and Needle GuideITX · Traditional | 11/24/1992SE |
| K920678 | Ultrasound Imagaing System and Doppler FlowmeterITX · Traditional | 04/02/1992SE |
| K911073 | Probe Refill KitITX · Traditional | 06/06/1991SE |
| K910049 | Interspec Apogee, ModificationDPW · Traditional | 04/29/1991SE |
| K903839 | Interspec ApogeeDXK · Traditional | 11/16/1990SE |
| K900155 | Interspec 2 MHZ, Transcranial Pulsed Wave DopplerITX · Traditional | 10/05/1990SE |
| K892944 | Interspec Transesophageal Probe Model 4515JOP · Traditional | 07/19/1989SE |
| K890173 | Interspec ApogeeIYO · Traditional | 04/14/1989SE |
Questions and answers
When was Cardioscan with Doppler Option cleared by the FDA?
Cardioscan with Doppler Option (K862913) received a 510(k) decision of Substantially Equivalent on November 4, 1986, 95 days after the submission was received.
What is the product code of K862913?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.