The following data is part of a premarket notification filed by Arzbaecher & Co. with the FDA for Esophageal Ecg Preamplifier & Signal Con.
| Device ID | K792283 |
| 510k Number | K792283 |
| Device Name: | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | ARZBAECHER & CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-13 |
| Decision Date | 1979-11-21 |