WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH— 510(k) K982283

Substantially Equivalent

Caradyne, Ltd.

FDA 510(k) clearance K982283 for WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH, Substantially Equivalent on 1999-03-09. Applicant: Caradyne, Ltd..

Clearance details

Applicant: Caradyne, Ltd.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1998-06-30
Decision date: 1999-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mccordsville, IN, US

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.