The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Cardiotest Ek 53 R, Cardiognost Ek 56/ Ek 512.
| Device ID | K900246 |
| 510k Number | K900246 |
| Device Name: | CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512 |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-17 |
| Decision Date | 1990-07-03 |