K3 SYSTEM— 510(k) K934644

Substantially Equivalent

Astro-Med, Inc.

FDA 510(k) clearance K934644 for K3 SYSTEM, Substantially Equivalent on 1994-11-01. Applicant: Astro-Med, Inc..

Clearance details

Applicant: Astro-Med, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1993-09-29
Decision date: 1994-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Warwick, RI, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.