510(k) K900104— TCPM II TOURNIQUET CUFF PRESSURE MONITOR

Substantially Equivalent

Electromedics, Inc.

Clearance details

Applicant: Electromedics, Inc.
Product code: Code KCY
Advisory panel: General, Plastic Surgery
Date received: 1990-01-09
Decision date: 1990-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.