The following data is part of a premarket notification filed by Maersk Medical A/s with the FDA for Disposable Ecg Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, And 4560.
| Device ID | K990113 |
| 510k Number | K990113 |
| Device Name: | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 |
| Classification | Electrode, Electrocardiograph |
| Applicant | MAERSK MEDICAL A/S 6401 MEADOWS WEST Fort Worth, TX 76132 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer MAERSK MEDICAL A/S 6401 MEADOWS WEST Fort Worth, TX 76132 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-13 |
| Decision Date | 1999-12-06 |
| Summary: | summary |