The following data is part of a premarket notification filed by Consolidated Medical Equipment, Inc. with the FDA for Esophageal Ecg Preamplifier & Signal Con.
| Device ID | K802282 |
| 510k Number | K802282 |
| Device Name: | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | CONSOLIDATED MEDICAL EQUIPMENT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-19 |
| Decision Date | 1980-10-10 |