LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.— 510(k) K863535

Substantially Equivalent

Computerized Medical Systems, Inc.

FDA 510(k) clearance K863535 for LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD., Substantially Equivalent on 1987-01-06. Applicant: Computerized Medical Systems, Inc..

Clearance details

Applicant: Computerized Medical Systems, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1986-09-11
Decision date: 1987-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.