ECHOINSIGHT
System, Image Processing, Radiological
ULTRASOUND MEDICAL DEVICES, INC.
The following data is part of a premarket notification filed by Ultrasound Medical Devices, Inc. with the FDA for Echoinsight.
Pre-market Notification Details
| Device ID | K110447 |
| 510k Number | K110447 |
| Device Name: | ECHOINSIGHT |
| Classification | System, Image Processing, Radiological |
| Applicant | ULTRASOUND MEDICAL DEVICES, INC. 3917 RESEARCH PARK DRIVE Ann Arbor, MI 48108 |
| Contact | Paul Kortesoja |
| Correspondent | Paul Kortesoja ULTRASOUND MEDICAL DEVICES, INC. 3917 RESEARCH PARK DRIVE Ann Arbor, MI 48108 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-16 |
| Decision Date | 2011-05-27 |
| Summary: | summary |
Trademark Results [ECHOINSIGHT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ECHOINSIGHT 86014739 4490971 Live/Registered |
Echo Insight, LLC 2013-07-19 |
 ECHOINSIGHT 85065810 4020411 Live/Registered |
Ultrasound Medical Devices, Inc. 2010-06-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.