GEM-CRIT CHECK— 510(k) K871686

Substantially Equivalent

Diamond Sensor Systems

FDA 510(k) clearance K871686 for GEM-CRIT CHECK, Substantially Equivalent on 1987-06-18. Applicant: Diamond Sensor Systems.

Clearance details

Applicant: Diamond Sensor Systems
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 1987-04-29
Decision date: 1987-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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Adverse events under product code DRY

product code DRY

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.