The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Tlink Data Management System (dms).
| Device ID | K113214 |
| 510k Number | K113214 |
| Device Name: | TLINK DATA MANAGEMENT SYSTEM (DMS) |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Rebecca Andersen |
| Correspondent | Rebecca Andersen TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-02-07 |
| Summary: | summary |