The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Ilook 25 Needle Guide Attachment And Bracket Assembly.
| Device ID | K030064 |
| 510k Number | K030064 |
| Device Name: | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-01-07 |
| Decision Date | 2003-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436110075 | K030064 | 000 |
| 00841436181204 | K030064 | 000 |
| 00841436181211 | K030064 | 000 |
| 00841436107013 | K030064 | 000 |
| 00841436107020 | K030064 | 000 |
| 00841436107037 | K030064 | 000 |
| 00841436110105 | K030064 | 000 |
| 00841436110112 | K030064 | 000 |
| 00841436110129 | K030064 | 000 |
| 00841436110051 | K030064 | 000 |
| 00841436110068 | K030064 | 000 |
| 00841436181198 | K030064 | 000 |