The following data is part of a premarket notification filed by Carefusion 303, Inc. with the FDA for Multi-link X2 Ecg Adapter And Direct Connect Lead Wire System.
| Device ID | K163316 |
| 510k Number | K163316 |
| Device Name: | Multi-Link X2 ECG Adapter And Direct Connect Lead Wire System |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | CAREFUSION 303, INC. 75 N Fairway Drive Vernon Hills, IL 60061 |
| Contact | Erika Fernandez |
| Correspondent | Erika Fernandez CAREFUSION 303, INC. 75 N Fairway Drive Vernon Hills, IL 60061 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-23 |
| Decision Date | 2017-06-22 |
| Summary: | summary |