VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840— 510(k) K063650

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K063650 for VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840, Substantially Equivalent on 2007-02-15. Applicant: Puritan Bennett Corp..

Clearance details

Applicant: Puritan Bennett Corp.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2006-12-08
Decision date: 2007-02-15
Decision: Substantially Equivalent
Clearance type: Special
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.