The following data is part of a premarket notification filed by Dymax Corp. with the FDA for Site-rite Iv Ultrasound System.
| Device ID | K032135 |
| 510k Number | K032135 |
| Device Name: | SITE-RITE IV ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DYMAX CORP. 271 KAPPA DR. Pittsburgh, PA 15238 |
| Contact | Charles Morreale |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-11 |
| Decision Date | 2003-07-21 |
| Summary: | summary |