FLO TEM II (BLOOD/FLUID WARMER— 510(k) K813161

Substantially Equivalent

Datachem, Inc.

FDA 510(k) clearance K813161 for FLO TEM II (BLOOD/FLUID WARMER, Substantially Equivalent on 1981-12-09. Applicant: Datachem, Inc..

Clearance details

Applicant: Datachem, Inc.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 1981-11-10
Decision date: 1981-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.