V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE— 510(k) K110083

Substantially Equivalent

Respironics California, Inc.

FDA 510(k) clearance K110083 for V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE, Substantially Equivalent on 2012-01-13. Applicant: Respironics California, Inc..

Clearance details

Applicant: Respironics California, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2011-01-11
Decision date: 2012-01-13
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.