THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300— 510(k) K073363

Substantially Equivalent

Paladin Biomedical Corporation

FDA 510(k) clearance K073363 for THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300, Substantially Equivalent on 2008-03-20. Applicant: Paladin Biomedical Corporation.

Clearance details

Applicant: Paladin Biomedical Corporation
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2007-11-30
Decision date: 2008-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.