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

Name: FDA 510(k) clearance K844856
Creator: U.S. Food and Drug Administration
Published: 1985-02-20

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.. Device class: 2.

Clearance details

Applicant: Bristol Medical Electronics Corp.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
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 ↗

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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.