The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Hand-carried Ultrasound System.
Device ID | K010374 |
510k Number | K010374 |
Device Name: | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SONOSITE,INC. 21919 30TH DRIVE SE. Bothell, WA 98021 -3904 |
Contact | Michael A Hoffman |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2001-02-07 |
Decision Date | 2001-02-21 |