The following data is part of a premarket notification filed by Pie Medical with the FDA for 50s Tringa Ultrasound Imaging System.
Device ID | K020112 |
510k Number | K020112 |
Device Name: | 50S TRINGA ULTRASOUND IMAGING SYSTEM |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | PIE MEDICAL 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
Contact | Colleen Densmore |
Correspondent | Colleen Densmore PIE MEDICAL 8000 CASTLEWAY DR. 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 | 2002-01-11 |
Decision Date | 2002-04-19 |
Summary: | summary |