COMPUSPEAK— 510(k) K941566

Substantially Equivalent

Hogan & Hartson

FDA 510(k) clearance K941566 for COMPUSPEAK, Substantially Equivalent on 1995-06-30. Applicant: Hogan & Hartson.

Clearance details

Applicant: Hogan & Hartson
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1994-04-01
Decision date: 1995-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.