V60 VENTILATOR, MODEL V8000— 510(k) K082660

Substantially Equivalent

Respironics California, Inc.

FDA 510(k) clearance K082660 for V60 VENTILATOR, MODEL V8000, Substantially Equivalent on 2009-01-09. Applicant: Respironics California, Inc..

Clearance details

Applicant: Respironics California, Inc.
Product code: Code MNT
Advisory panel: Anesthesiology
Date received: 2008-09-12
Decision date: 2009-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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Adverse events under product code MNT

product code MNT

Death: 118
Injury: 324
Malfunction: 25,451
Other: 2
Total: 25,895

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.