The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Baby Mac Electrocardiograph Electrode.
| Device ID | K895834 |
| 510k Number | K895834 |
| Device Name: | BABY MAC ELECTROCARDIOGRAPH ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | MARQUETTE ELECTRONICS, INC. P.O. BOX 9100 100 MARQUETTE DRIVE Jupiter, FL 33468 |
| Contact | Michael T Laughran |
| Correspondent | Michael T Laughran MARQUETTE ELECTRONICS, INC. P.O. BOX 9100 100 MARQUETTE DRIVE Jupiter, FL 33468 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-02 |
| Decision Date | 1989-11-03 |