510(k) K833902
- Device
- VASOSCAN
- Applicant
- SONICAID, INC.
- 510(k) number
- K833902
- Product code
- JOP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-27
- Date received
- 1983-11-14
- Regulation
- 870.2880
- Classification name
- Transducer, Ultrasonic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1216677
- 1820334
- 3010611950
- 3006116468
- 3020115
- 1937397
- 3010389834
- 3000126629
- 3033275035
- 1000393132
- 3006648308
- 3009286597
- 9611033
- 8043817
- 3010089756
- 2522007
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JOP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix , Ltd. | 2024-12-18 |
| K233976 | VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC | 2024-07-19 |
| K153762 | Smartdop XT6 | Koven Technology, Inc. | 2016-05-25 |
| K131623 | SMARTDOP XT | Koven Technology, Inc. | 2014-01-17 |
| K131860 | VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING | Us Vascular, LLC | 2013-09-27 |
| K111416 | FALCON | Viasonix , Ltd. | 2011-07-15 |
| K071730 | STUDIODOP VICORDER | Skidmore Medical, Limited | 2007-12-20 |
| K010482 | ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 | Echocath, Inc. | 2001-03-20 |
| K002766 | NICOLET VASOGUARD | Nicolet Biomedical | 2000-11-30 |
| K990642 | ECHOFLOW DOPPLER BLOOD VELOCITY METER | Echocath, Inc. | 1999-09-16 |
| K925078 | SPECTRADOP | Bennett and Assoc., Inc. | 1995-07-17 |
| K934638 | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 | Koven Technology, Inc. | 1994-05-13 |
| K912409 | MODEL HD-207 BIDIRECTIONAL VELOCITY METER | Koven and Assoc., Inc. | 1991-12-23 |
| K911320 | EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE | Applied Biometrics, Inc. | 1991-12-18 |
| K910281 | INTRAVASCULAR IMAGING SYSTEM/MODIFIED | Intertherapy, Inc. | 1991-05-13 |
Legacy Summary#
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FDA Review#
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