PROTEGE LIQUID OXYGEN SYSTEM— 510(k) K971545

Substantially Equivalent

Healthdyne Technologies, Inc.

FDA 510(k) clearance K971545 for PROTEGE LIQUID OXYGEN SYSTEM, Substantially Equivalent on 1997-07-25. Applicant: Healthdyne Technologies, Inc..

Clearance details

Applicant: Healthdyne Technologies, Inc.
Product code: Code BYJ
Advisory panel: Anesthesiology
Date received: 1997-04-28
Decision date: 1997-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

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.