The following data is part of a premarket notification filed by Ge Medical Sysyems Ultrasound & Primary Care Diagn with the FDA for Vscan With Dual Probe.
| Device ID | K140693 |
| 510k Number | K140693 |
| Device Name: | VSCAN WITH DUAL PROBE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-19 |
| Decision Date | 2014-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682107891 | K140693 | 000 |