MODIFICATION TO ARKIVE(TM)— 510(k) K872178

Substantially Equivalent

Diatek, Inc.

FDA 510(k) clearance K872178 for MODIFICATION TO ARKIVE(TM), Substantially Equivalent on 1988-01-27. Applicant: Diatek, Inc..

Clearance details

Applicant: Diatek, Inc.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 1987-06-08
Decision date: 1988-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.