The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Disposable Ecg Electrode.
| Device ID | K041734 |
| 510k Number | K041734 |
| Device Name: | AMBU DISPOSABLE ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | AMBU, INC. 611 NORTH HAMMONDS FERRY ROAD Linthicum, MD 21090 -1356 |
| Contact | Sanjay Parikh |
| Correspondent | Sanjay Parikh AMBU, INC. 611 NORTH HAMMONDS FERRY ROAD Linthicum, MD 21090 -1356 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-25 |
| Decision Date | 2004-09-22 |