The following data is part of a premarket notification filed by Pie Medical with the FDA for Tringa Ultrasound Imaging System, Model 50l.
| Device ID | K033604 |
| 510k Number | K033604 |
| Device Name: | TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Colleen Densmore |
| Correspondent | Colleen Densmore 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 | 2003-11-17 |
| Decision Date | 2003-12-15 |
| Summary: | summary |