The following data is part of a premarket notification filed by Pie Medical with the FDA for 100 S And 100 Lc And 485 Anser Ultrasound Imaging Systems.
| Device ID | K002357 |
| 510k Number | K002357 |
| Device Name: | 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS |
| Classification | System, Imaging, Pulsed Echo, 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-02 |
| Decision Date | 2000-11-09 |