UNIVERSAL TEMP. PACING ELECT. #080-10000— 510(k) K801800

Substantially Equivalent

Medical Testing System, Inc.

FDA 510(k) clearance K801800 for UNIVERSAL TEMP. PACING ELECT. #080-10000, Substantially Equivalent on 1980-10-23. Applicant: Medical Testing System, Inc..

Clearance details

Applicant: Medical Testing System, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1980-07-29
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.