ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON— 510(k) K844856

Substantially Equivalent

Bristol Medical Electronics Corp.

FDA 510(k) clearance K844856 for ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON, Substantially Equivalent on 1985-02-20. Applicant: Bristol Medical Electronics Corp..

Clearance details

Applicant: Bristol Medical Electronics Corp.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1984-12-14
Decision date: 1985-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.