The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Ecg/ekg Electrodes.
| Device ID | K954389 |
| 510k Number | K954389 |
| Device Name: | CONMED ECG/EKG ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Contact | Ira D Duesler, Jr. |
| Correspondent | Ira D Duesler, Jr. CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-19 |
| Decision Date | 1996-05-16 |