DYE CURVE EVALUATOR— 510(k) K792135

Substantially Equivalent

Sci-Pro, Inc.

FDA 510(k) clearance K792135 for DYE CURVE EVALUATOR, Substantially Equivalent on 1980-01-11. Applicant: Sci-Pro, Inc..

Clearance details

Applicant: Sci-Pro, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1979-10-22
Decision date: 1980-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.