Ultramed TF 122 Ultrason Vascu Imag & Doppler Syst
FDA 510(k) K861378 · Ultramed, Inc.
510(k) numberK861378
Submission
- Device name
- Ultramed TF 122 Ultrason Vascu Imag & Doppler Syst
- Applicant
- Ultramed, Inc.
North Brunswick, NJ, US - Received
- April 14, 1986
- Decision date
- July 7, 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
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 |
|---|---|---|
| K882015 | Transcran(Tm) Transcranial Pulsed Doppler SystemIYN · Traditional | 09/08/1988SE |
| K873989 | Dopplex Ultrasonic Doppler SystemJOP · Traditional | 03/02/1988SE |
| K862021 | Phacoemulsification Ultrasonic Fragment SystemHQC · Traditional | 06/23/1986SE |
| K850578 | Phacoemulsification TipHQC · Traditional | 04/03/1985SE |
Questions and answers
When was Ultramed TF 122 Ultrason Vascu Imag & Doppler Syst cleared by the FDA?
Ultramed TF 122 Ultrason Vascu Imag & Doppler Syst (K861378) received a 510(k) decision of Substantially Equivalent on July 7, 1986, 84 days after the submission was received.
What is the product code of K861378?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.