The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Electrocardiograph #334.
| Device ID | K823488 |
| 510k Number | K823488 |
| Device Name: | ELECTROCARDIOGRAPH #334 |
| Classification | Electrocardiograph |
| Applicant | BIRTCHER CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-23 |
| Decision Date | 1982-12-30 |