The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Self-retaining Electrode Ser. #4000-100.
| Device ID | K780908 |
| 510k Number | K780908 |
| Device Name: | SELF-RETAINING ELECTRODE SER. #4000-100 |
| Classification | Electrode, Electrocardiograph |
| Applicant | ANDOVER MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-05 |
| Decision Date | 1978-06-19 |