The following data is part of a premarket notification filed by Coactiv, Llc with the FDA for Exam-pacs.
Device ID | K042647 |
510k Number | K042647 |
Device Name: | EXAM-PACS |
Classification | System, Image Processing, Radiological |
Applicant | COACTIV, LLC 1100 LAKEVIEW BLVD Denton, TX 76208 |
Contact | Carl Alletto |
Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-09-28 |
Decision Date | 2004-10-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EXAM-PACS 78342259 2916419 Live/Registered |
Coactiv, LLC 2003-12-17 |