The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed 2710 Cleartrace 2 Lt Monitoring Ecg Electrode.
| Device ID | K954388 |
| 510k Number | K954388 |
| Device Name: | CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
| Contact | Ira D Duesler, Jr. |
| Correspondent | Ira D Duesler, Jr. CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
| 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 | 1996-02-06 |