The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Life-watch Monitor Lt-8.
| Device ID | K863534 |
| 510k Number | K863534 |
| Device Name: | LIFE-WATCH MONITOR LT-8 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 3555 WOODHEAD DR. Northbrook, IL 60062 |
| Contact | Gary Hendrickson |
| Correspondent | Gary Hendrickson COMPUTERIZED MEDICAL SYSTEMS, INC. 3555 WOODHEAD DR. Northbrook, IL 60062 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-11 |
| Decision Date | 1986-11-21 |