The following data is part of a premarket notification filed by Conmed Andover Medical, Inc. with the FDA for 2700 Cleartrace Radiotranslucent Monitoring Ecg Electrobe.
| Device ID | K944849 |
| 510k Number | K944849 |
| Device Name: | 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE |
| Classification | Electrode, Electrocardiograph |
| Applicant | CONMED ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01832 -1398 |
| Contact | Brenda Cullinane |
| Correspondent | Brenda Cullinane CONMED ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01832 -1398 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-30 |
| Decision Date | 1994-10-17 |