The following data is part of a premarket notification filed by Opko Instrumentation, Inc with the FDA for Oti-scan 3000.
| Device ID | K092837 |
| 510k Number | K092837 |
| Device Name: | OTI-SCAN 3000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | OPKO INSTRUMENTATION, INC 4400 BISCAYNE BLVD Miami, FL 33137 |
| Contact | Mario Arbesu |
| Correspondent | Mario Arbesu OPKO INSTRUMENTATION, INC 4400 BISCAYNE BLVD Miami, FL 33137 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-15 |
| Decision Date | 2009-12-23 |