MASTER-NEB NEBULIZER COMPRESSOR SYSTEM— 510(k) K943717

Substantially Equivalent

Howard K. Mann & Assoc.

FDA 510(k) clearance K943717 for MASTER-NEB NEBULIZER COMPRESSOR SYSTEM, Substantially Equivalent on 1995-09-12. Applicant: Howard K. Mann & Assoc..

Clearance details

Applicant: Howard K. Mann & Assoc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1994-08-01
Decision date: 1995-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, 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.