INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456— 510(k) K042655

Substantially Equivalent

Respironics New Jersey, Inc.

FDA 510(k) clearance K042655 for INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456, Substantially Equivalent on 2004-10-13. Applicant: Respironics New Jersey, Inc..

Clearance details

Applicant: Respironics New Jersey, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2004-09-28
Decision date: 2004-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Grove, 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.