MULTICHANNEL TELEMETRY SYSTEM— 510(k) K801944

Substantially Equivalent

Burdick Corp.

FDA 510(k) clearance K801944 for MULTICHANNEL TELEMETRY SYSTEM, Substantially Equivalent on 1980-10-23. Applicant: Burdick Corp..

Clearance details

Applicant: Burdick Corp.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 1980-08-14
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.