TEMPO AND TEMP H20— 510(k) K973748

Substantially Equivalent

Smith

FDA 510(k) clearance K973748 for TEMPO AND TEMP H20, Substantially Equivalent on 1998-03-10. Applicant: Smith.

Clearance details

Applicant: Smith
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 1997-10-01
Decision date: 1998-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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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.