The following data is part of a premarket notification filed by Marquette Medical Systems, Inc. with the FDA for Multi-link Cable And Lead Wire Systems.
| Device ID | K980582 |
| 510k Number | K980582 |
| Device Name: | MULTI-LINK CABLE AND LEAD WIRE SYSTEMS |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | MARQUETTE MEDICAL SYSTEMS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
| Contact | Michael Laughran |
| Correspondent | Michael Laughran MARQUETTE MEDICAL SYSTEMS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-03-16 |
| Summary: | summary |