HEATER WIRE BREATHING CIRCUIT— 510(k) K873179

Substantially Equivalent

Life Design Systems, Inc.

FDA 510(k) clearance K873179 for HEATER WIRE BREATHING CIRCUIT, Substantially Equivalent on 1988-03-31. Applicant: Life Design Systems, Inc..

Clearance details

Applicant: Life Design Systems, Inc.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1987-08-12
Decision date: 1988-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, WI, 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.