The following data is part of a premarket notification filed by Intl. Products, Inc. with the FDA for Pc Based Electrocardiograph System (pc-ecg).
| Device ID | K963578 |
| 510k Number | K963578 |
| Device Name: | PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) |
| Classification | Electrocardiograph |
| Applicant | INTL. PRODUCTS, INC. 8106 MEADOW SPRINGS CT. Vienna, VA 22182 |
| Contact | Uwe Klootz |
| Correspondent | Uwe Klootz INTL. PRODUCTS, INC. 8106 MEADOW SPRINGS CT. Vienna, VA 22182 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-06 |
| Decision Date | 1997-06-30 |
| Summary: | summary |