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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889483578452 | K163316 | 000 |
| 20889483577995 | K163316 | 000 |
| 20889483577988 | K163316 | 000 |
| 20889483577971 | K163316 | 000 |
| 20889483577964 | K163316 | 000 |
| 20889483577957 | K163316 | 000 |
| 20889483577940 | K163316 | 000 |
| 20889483577933 | K163316 | 000 |
| 20889483577926 | K163316 | 000 |
| 20889483577919 | K163316 | 000 |
| 20889483577902 | K163316 | 000 |
| 10889483577844 | K163316 | 000 |
| 10889483577837 | K163316 | 000 |
| 10889483577820 | K163316 | 000 |
| 10889483577813 | K163316 | 000 |
| 20889483578022 | K163316 | 000 |
| 20889483578039 | K163316 | 000 |
| 20889483578046 | K163316 | 000 |
| 20889483578015 | K163316 | 000 |
| 20889483578008 | K163316 | 000 |
| 20889483578541 | K163316 | 000 |
| 20889483578534 | K163316 | 000 |
| 10889483578445 | K163316 | 000 |
| 20889483578527 | K163316 | 000 |
| 20889483578510 | K163316 | 000 |
| 20889483578503 | K163316 | 000 |
| 20889483578497 | K163316 | 000 |
| 10889483578469 | K163316 | 000 |
| 20889483578091 | K163316 | 000 |
| 20889483578077 | K163316 | 000 |
| 20889483578060 | K163316 | 000 |
| 20889483578053 | K163316 | 000 |
| 10889483577806 | K163316 | 000 |