The following data is part of a premarket notification filed by The Prometheus Group with the FDA for Morpheus Realtime Ultrasound, Pathway Realtime Ultrasound, Quickscan Bladder Ultrasound.
Device ID | K160792 |
510k Number | K160792 |
Device Name: | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | THE PROMETHEUS GROUP 1 WASHINGTON STREET SUITE 303 Dover, NH 03820 |
Contact | Joshua Bird |
Correspondent | Joshua Bird THE PROMETHEUS GROUP 1 WASHINGTON STREET SUITE 303 Dover, NH 03820 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-23 |
Decision Date | 2016-04-15 |
Summary: | summary |