The following data is part of a premarket notification filed by Dymax Corp. with the FDA for Site-rite 3 Ultrasound System.
| Device ID | K993624 |
| 510k Number | K993624 |
| Device Name: | SITE-RITE 3 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DYMAX CORP. 271 KAPPA DR. Pittsburgh, PA 15238 |
| Contact | Charles Morreale |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-10-26 |
| Decision Date | 1999-11-10 |
| Summary: | summary |