The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Ecg Patient Safety Cables And Leadwires-removal And Permanently-attached Leadwires.
| Device ID | K945034 |
| 510k Number | K945034 |
| Device Name: | CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Contact | Ira D Duesler |
| Correspondent | Ira D Duesler CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-13 |
| Decision Date | 1994-10-27 |