The following data is part of a premarket notification filed by Classic Medical Products, Inc. with the FDA for Classic Ecg/stimulating No. 1700 Series.
| Device ID | K900519 |
| 510k Number | K900519 |
| Device Name: | CLASSIC ECG/STIMULATING NO. 1700 SERIES |
| Classification | Electrode, Electrocardiograph |
| Applicant | CLASSIC MEDICAL PRODUCTS, INC. S82 W 19246 APOLLO DR. Muskego, WI 53150 |
| Contact | Robert A Macur |
| Correspondent | Robert A Macur CLASSIC MEDICAL PRODUCTS, INC. S82 W 19246 APOLLO DR. Muskego, WI 53150 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-02 |
| Decision Date | 1990-03-19 |