The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Vitastat Ecg-1/ecg-3 Electrocardiograph.
| Device ID | K803309 |
| 510k Number | K803309 |
| Device Name: | VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-01-16 |