The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Automatic Single Channel Ecg #399.
| Device ID | K821888 |
| 510k Number | K821888 |
| Device Name: | AUTOMATIC SINGLE CHANNEL ECG #399 |
| Classification | Electrocardiograph |
| Applicant | BIRTCHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-25 |
| Decision Date | 1982-07-30 |