The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Ecg Patient Safety Cables And Leadwires-removal And Permanently-attached Leadwires.
Device ID | K945034 |
510k Number | K945034 |
Device Name: | CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Contact | Ira D Duesler |
Correspondent | Ira D Duesler CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-13 |
Decision Date | 1994-10-27 |