N-D0-SURE— 510(k) K811185

Substantially Equivalent

Ackrad Laboratories

FDA 510(k) clearance K811185 for N-D0-SURE, Substantially Equivalent on 1981-06-02. Applicant: Ackrad Laboratories.

Clearance details

Applicant: Ackrad Laboratories
Product code: Code CBH
Advisory panel: Anesthesiology
Date received: 1981-04-29
Decision date: 1981-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CBH

product code CBH

Death: 7
Total: 7

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.