TEMPERATURE CONTROLLER MODEL 17000— 510(k) K781530

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K781530 for TEMPERATURE CONTROLLER MODEL 17000, Substantially Equivalent on 1978-11-14. Applicant: Healthdyne, Inc..

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1978-09-06
Decision date: 1978-11-14
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.