The following data is part of a premarket notification filed by Carolina Medical, Inc. with the FDA for Pr3 Ultrasound System.
| Device ID | K993978 |
| 510k Number | K993978 |
| Device Name: | PR3 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CAROLINA MEDICAL, INC. 157 INDUSTRIAL DR. King, NC 27021 |
| Contact | Carroll L Turner |
| Correspondent | Carroll L Turner CAROLINA MEDICAL, INC. 157 INDUSTRIAL DR. King, NC 27021 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-02-10 |