The following data is part of a premarket notification filed by Biomedical Systems, Inc. with the FDA for Century Color Trace.
| Device ID | K884152 |
| 510k Number | K884152 |
| Device Name: | CENTURY COLOR TRACE |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | BIOMEDICAL SYSTEMS, INC. 77 WEST PORT PLAZA St. Louis, MO 63146 |
| Contact | Timothy R Barrett |
| Correspondent | Timothy R Barrett BIOMEDICAL SYSTEMS, INC. 77 WEST PORT PLAZA St. Louis, MO 63146 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-03 |
| Decision Date | 1988-12-15 |