The following data is part of a premarket notification filed by Medicotest, Inc. with the FDA for Br-50-j Disposable Ecg Electrode.
| Device ID | K921579 |
| 510k Number | K921579 |
| Device Name: | BR-50-J DISPOSABLE ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | MEDICOTEST, INC. ONE METROPOLITAN SQUARE 211 NORTH BROADWAY, SUITE 3600 St. Louis, MO 63102 |
| Contact | Melissa G Burns |
| Correspondent | Melissa G Burns MEDICOTEST, INC. ONE METROPOLITAN SQUARE 211 NORTH BROADWAY, SUITE 3600 St. Louis, MO 63102 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-02 |
| Decision Date | 1992-05-26 |