A.M.S. TEMP. SCAN 300— 510(k) K832135

Substantially Equivalent

Andon Medical Systems, Inc.

FDA 510(k) clearance K832135 for A.M.S. TEMP. SCAN 300, Substantially Equivalent on 1983-08-16. Applicant: Andon Medical Systems, Inc..

Clearance details

Applicant: Andon Medical Systems, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1983-07-01
Decision date: 1983-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.