The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Hand-carried Ultrasound System (c2 Series).
Device ID | K023957 |
510k Number | K023957 |
Device Name: | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SONOSITE,INC. 21919 30TH DRIVE SE. Bothell, WA 98021 -3904 |
Contact | Michael A Hoffman |
Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2002-11-27 |
Decision Date | 2002-12-12 |
Summary: | summary |