TA-2 TEMPERATURE ALARM— 510(k) K770984

Substantially Equivalent

Mistogen Equipment Co.

FDA 510(k) clearance K770984 for TA-2 TEMPERATURE ALARM, Substantially Equivalent on 1977-07-05. Applicant: Mistogen Equipment Co..

Clearance details

Applicant: Mistogen Equipment Co.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1977-05-31
Decision date: 1977-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.