The following data is part of a premarket notification filed by Arzbaecher & Co. with the FDA for Esophageal Pill-electrode.
| Device ID | K800201 |
| 510k Number | K800201 |
| Device Name: | ESOPHAGEAL PILL-ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | ARZBAECHER & CO. 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 | 1980-01-30 |
| Decision Date | 1980-02-26 |