PLV CONTINUUM VENTILATOR, MODEL P2000— 510(k) K034032

Substantially Equivalent

Respironics California, Inc.

FDA 510(k) clearance K034032 for PLV CONTINUUM VENTILATOR, MODEL P2000, Substantially Equivalent on 2004-03-16. Applicant: Respironics California, Inc..

Clearance details

Applicant: Respironics California, Inc.
Product code: Code NOU
Advisory panel: Anesthesiology
Date received: 2003-12-29
Decision date: 2004-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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Adverse events under product code NOU

product code NOU

Death: 65
Injury: 138
Malfunction: 3,664
Other: 1
Total: 3,868

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.