The following data is part of a premarket notification filed by Ultrasound Medical Devices, Inc. with the FDA for Ultra Dci Model 5000.
| Device ID | K100363 |
| 510k Number | K100363 |
| Device Name: | ULTRA DCI MODEL 5000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-05-21 |
| Summary: | summary |