JOP — Transducer, Ultrasonic Class II
FDA product code JOP covers "Transducer, Ultrasonic", a Class II medical device regulated under 21 CFR 870.2880. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOP
- Device Class
- Class II
- Regulation Number
- 870.2880
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242662 | viasonix | Falcon/Xpress (Falcon/Xpress) | December 18, 2024 |
| K233976 | corvascular diagnostics | VasoGuard (V10, V8, V6, V4, V2) | July 19, 2024 |
| K153762 | koven technology | Smartdop XT6 | May 25, 2016 |
| K131623 | koven technology | SMARTDOP XT | January 17, 2014 |
| K131860 | us vascular | VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING | September 27, 2013 |
| K111416 | viasonix | FALCON | July 15, 2011 |
| K071730 | skidmore medical, limited | STUDIODOP VICORDER | December 20, 2007 |
| K010482 | echocath | ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 | March 20, 2001 |
| K002766 | nicolet biomedical | NICOLET VASOGUARD | November 30, 2000 |
| K990642 | echocath | ECHOFLOW DOPPLER BLOOD VELOCITY METER | September 16, 1999 |
| K925078 | bennett and assoc | SPECTRADOP | July 17, 1995 |
| K934638 | koven technology | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 | May 13, 1994 |
| K912409 | koven and assoc | MODEL HD-207 BIDIRECTIONAL VELOCITY METER | December 23, 1991 |
| K911320 | applied biometrics | EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE | December 18, 1991 |
| K910281 | intertherapy | INTRAVASCULAR IMAGING SYSTEM/MODIFIED | May 13, 1991 |
| K905157 | advance medical device | FLOSCOPE VASCULAR LAB. | March 15, 1991 |
| K905369 | ge medical systems information technologies | UST-2266U-5 CW DOPPLER TRANSDUCER | February 11, 1991 |
| K896264 | millar instruments | MILLAR MIKRO-TIP DOPPLER CATHETER | January 24, 1990 |
| K890638 | elscint | VOLUME COMPUTATION SOFTWARE PACKAGE | August 7, 1989 |
| K890636 | elscint | CARDIAC COMPUTATION SOFTWARE PACKAGE | August 7, 1989 |