VITAL FLOW NASAL CPAP SYSTEM— 510(k) K860848

Substantially Equivalent

Systems 2000, Inc.

FDA 510(k) clearance K860848 for VITAL FLOW NASAL CPAP SYSTEM, Substantially Equivalent on 1986-06-12. Applicant: Systems 2000, Inc..

Clearance details

Applicant: Systems 2000, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1986-03-06
Decision date: 1986-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, CA, US

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.