HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS— 510(k) K030515

Substantially Equivalent

Hans Rudolph, Inc.

FDA 510(k) clearance K030515 for HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS, Substantially Equivalent on 2003-05-02. Applicant: Hans Rudolph, Inc..

Clearance details

Applicant: Hans Rudolph, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2003-02-19
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.