The following data is part of a premarket notification filed by Tyco Electronics Corporation with the FDA for Tyco Electronics Electrocardiograph (ecg) Leadwire Set.
| Device ID | K102430 |
| 510k Number | K102430 |
| Device Name: | TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | TYCO ELECTRONICS CORPORATION 10025 SW FREEMAN CT. Wilsonville, OR 97070 |
| Contact | Dennis M Gilkey |
| Correspondent | Dawn Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-08-26 |
| Decision Date | 2010-09-10 |
| Summary: | summary |