The following data is part of a premarket notification filed by Pie Medical with the FDA for 300lc Ultrasound Imaging Systems, Model 300lc.
| Device ID | K002880 |
| 510k Number | K002880 |
| Device Name: | 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Colleen J Hittle |
| Correspondent | Colleen J Hittle PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-15 |
| Decision Date | 2000-10-26 |