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 |