The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Workmate Claris System, Workmate Claris System Display Plus.
| Device ID | K151911 |
| 510k Number | K151911 |
| Device Name: | WorkMate Claris System, WorkMate Claris System Display Plus |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL ONE ST. JUDE MEDICAL DRIVE St. Paul, MN 55117 |
| Contact | Melissa Frank |
| Correspondent | Melissa Frank ST. JUDE MEDICAL ONE ST. JUDE MEDICAL DRIVE St. Paul, MN 55117 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-13 |
| Decision Date | 2015-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067001696 | K151911 | 000 |