GEM-6, WITH COMPONENTS— 510(k) K854357

Substantially Equivalent

Diamond Electro-Tech, Inc.

FDA 510(k) clearance K854357 for GEM-6, WITH COMPONENTS, Substantially Equivalent on 1986-01-08. Applicant: Diamond Electro-Tech, Inc..

Clearance details

Applicant: Diamond Electro-Tech, Inc.
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 1985-10-29
Decision date: 1986-01-08
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.