The following data is part of a premarket notification filed by Civco Medical Instruments Co Inc Dba Civco Medical Solutions with the FDA for Omni Trax Active Patient Tracker.
| Device ID | K143396 |
| 510k Number | K143396 |
| Device Name: | Omni TRAX Active Patient Tracker |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CIVCO Medical Instruments Co Inc Dba CIVCO Medical Solutions 102 FIRST STREET SOUTH Kalona, IA 52247 -4787 |
| Contact | Amanda Stahle |
| Correspondent | Amanda Stable CIVCO Medical Instruments Co Inc Dba CIVCO Medical Solutions 102 FIRST STREET SOUTH Kalona, IA 52247 -4787 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-26 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436111768 | K143396 | 000 |
| 00841436110952 | K143396 | 000 |
| 00841436103121 | K143396 | 000 |