The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Exactrace Adult Foam Monitoring Ecg Electrode Conmed Model 1510 And Instatrace Adult Diaphoretic Foam Ecg Electrode Conm.
| Device ID | K963787 |
| 510k Number | K963787 |
| Device Name: | EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM |
| 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 | 1996-09-20 |
| Decision Date | 1997-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20851491007009 | K963787 | 000 |
| 10653405003694 | K963787 | 000 |
| 10653405003687 | K963787 | 000 |
| 10653405003670 | K963787 | 000 |
| 10653405003663 | K963787 | 000 |
| 10653405003649 | K963787 | 000 |
| 20653405003783 | K963787 | 000 |
| 20653405003776 | K963787 | 000 |
| 20653405003769 | K963787 | 000 |