RESPIFLO— 510(k) K962872

Unknown

Tyco Healthcare Deutschaland GmbH

FDA 510(k) clearance K962872 for RESPIFLO, Unknown on 1997-02-25. Applicant: Tyco Healthcare Deutschaland GmbH.

Clearance details

Applicant: Tyco Healthcare Deutschaland GmbH
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1996-07-23
Decision date: 1997-02-25
Decision: Unknown
Clearance type: Traditional
Location: Neustadt A D Donau, DE

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.