JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009— 510(k) K970035

Substantially Equivalent

Graham-Field, Inc.

FDA 510(k) clearance K970035 for JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009, Substantially Equivalent on 1997-04-01. Applicant: Graham-Field, Inc..

Clearance details

Applicant: Graham-Field, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1997-01-03
Decision date: 1997-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.