The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Jetstream Workspace.
Device ID | K061029 |
510k Number | K061029 |
Device Name: | JETSTREAM WORKSPACE |
Classification | System, Image Processing, Radiological |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Lori R Peterson |
Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-04-14 |
Decision Date | 2006-05-01 |
Summary: | summary |