The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Life-trace 18 Single-trace Cardiac Monitor/record..
| Device ID | K863535 |
| 510k Number | K863535 |
| Device Name: | LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. |
| Classification | Electrocardiograph |
| Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 3555 WOODHEAD DR. Northbrook, IL 60062 |
| Contact | Gary W Hendrickson |
| Correspondent | Gary W Hendrickson COMPUTERIZED MEDICAL SYSTEMS, INC. 3555 WOODHEAD DR. Northbrook, IL 60062 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-11 |
| Decision Date | 1987-01-06 |