The following data is part of a premarket notification filed by Abbott with the FDA for Workmate Claris System.
| Device ID | K210392 |
| 510k Number | K210392 |
| Device Name: | WorkMate Claris System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Abbott One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Ed Sandberg |
| Correspondent | Ed Sandberg Abbott One St. Jude Medical Drive St. Paul, MN 55117 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-10 |
| Decision Date | 2021-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067047229 | K210392 | 000 |
| 05415067047212 | K210392 | 000 |
| 05415067047205 | K210392 | 000 |
| 05415067047199 | K210392 | 000 |
| 05415067047182 | K210392 | 000 |
| 05415067047175 | K210392 | 000 |
| 05415067047168 | K210392 | 000 |
| 05415067001627 | K210392 | 000 |