The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Direct Writing Vectorcardiograph.
| Device ID | K810529 |
| 510k Number | K810529 |
| Device Name: | DIRECT WRITING VECTORCARDIOGRAPH |
| Classification | Vectorcardiograph |
| Applicant | ELMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYC |
| CFR Regulation Number | 870.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-26 |
| Decision Date | 1981-04-23 |