The following data is part of a premarket notification filed by La Jolla Technology, Inc. with the FDA for Ecg Interference Filter Tf-03.
| Device ID | K832888 |
| 510k Number | K832888 |
| Device Name: | ECG INTERFERENCE FILTER TF-03 |
| Classification | Electrocardiograph |
| Applicant | LA JOLLA TECHNOLOGY, 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 | 1983-08-26 |
| Decision Date | 1984-01-18 |