KWIK BOARD— 510(k) K930197

Substantially Equivalent

Astral, Ltd.

FDA 510(k) clearance K930197 for KWIK BOARD, Substantially Equivalent on 1993-04-20. Applicant: Astral, Ltd..

Clearance details

Applicant: Astral, Ltd.
Product code: Code KMK
Advisory panel: General Hospital
Date received: 1993-01-14
Decision date: 1993-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Rafael, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.