AMSCO WARMING CABINET— 510(k) K092823

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K092823 for AMSCO WARMING CABINET, Substantially Equivalent on 2009-12-18. Applicant: STERIS Corporation.

Clearance details

Applicant
STERIS Corporation
Product code
Code LGZ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mentor, OH, US
Download summary PDFView 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, through . 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.