The following data is part of a premarket notification filed by Ellex, Inc. with the FDA for I3 System-abd Diagnostic Ultrasound.
| Device ID | K103608 |
| 510k Number | K103608 |
| Device Name: | I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ELLEX, INC. 9940 BUSINESS PARK DR. SUITE 165 Sacramento, CA 95827 |
| Contact | Jonathan Strawn |
| Correspondent | Jonathan Strawn ELLEX, INC. 9940 BUSINESS PARK DR. SUITE 165 Sacramento, CA 95827 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-09 |
| Decision Date | 2010-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342395000274 | K103608 | 000 |
| 09342395001370 | K103608 | 000 |
| 09342395002285 | K103608 | 000 |
| 09342395002278 | K103608 | 000 |