The following data is part of a premarket notification filed by Advantage Medical Electronics, Inc. with the FDA for Patient Cables For Monitoring, I.e., Ecg, Ekg, Spo2, And Bp Interface Cables And Leadwires.
| Device ID | K992524 |
| 510k Number | K992524 |
| Device Name: | PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | ADVANTAGE MEDICAL ELECTRONICS, INC. 10630 WILES RD. Coral Springs, FL 33076 |
| Contact | Kenneth E Kendricks |
| Correspondent | Kenneth E Kendricks ADVANTAGE MEDICAL ELECTRONICS, INC. 10630 WILES RD. Coral Springs, FL 33076 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-28 |
| Decision Date | 2000-03-01 |
| Summary: | summary |