The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Hand-caried Untrasound System (powerseries).
| Device ID | K021628 |
| 510k Number | K021628 |
| Device Name: | SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) |
| 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 |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-05-17 |
| Decision Date | 2002-05-31 |
| Summary: | summary |