The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Cardiotest Ek53/ek53r, Cardiognost Ek56/ek512.
| Device ID | K890875 |
| 510k Number | K890875 |
| Device Name: | CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 |
| Classification | Electrocardiograph |
| Applicant | PPG INDUSTRIES, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Contact | John J Talarico |
| Correspondent | John J Talarico PPG INDUSTRIES, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-21 |
| Decision Date | 1989-10-17 |