TC-1000, TC-1050 SYSTEM— 510(k) K914805

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K914805 for TC-1000, TC-1050 SYSTEM, Substantially Equivalent on 1992-01-07. Applicant: Gaymar Industries, Inc..

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1991-10-24
Decision date: 1992-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

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Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.