The following data is part of a premarket notification filed by Bristol Medical Electronics Corp. with the FDA for Disposable Ecg Electrode.
| Device ID | K841944 |
| 510k Number | K841944 |
| Device Name: | DISPOSABLE ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | BRISTOL MEDICAL ELECTRONICS CORP. P.O. BOX 809 Mansfield , MA 02048 - |
| Contact | Michael R Dupelle |
| Correspondent | Michael R Dupelle BRISTOL MEDICAL ELECTRONICS CORP. P.O. BOX 809 Mansfield , MA 02048 - |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-11 |
| Decision Date | 1985-03-01 |