MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50— 510(k) K920002

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K920002 for MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50, Substantially Equivalent on 1992-11-10. Applicant: Puritan Bennett Corp..

Clearance details

Applicant: Puritan Bennett Corp.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 1992-01-02
Decision date: 1992-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, 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.