The following data is part of a premarket notification filed by Tronomed, Inc. with the FDA for Electrocardiographic Cablhs & Lead Wire.
| Device ID | K771645 |
| 510k Number | K771645 |
| Device Name: | ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | TRONOMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-29 |
| Decision Date | 1977-10-18 |