ALTERA NEBULIZER SYSTEM, MODEL 678G1002— 510(k) K100380

Substantially Equivalent

Pari Respiratory Equipment, Inc.

FDA 510(k) clearance K100380 for ALTERA NEBULIZER SYSTEM, MODEL 678G1002, Substantially Equivalent on 2010-02-22. Applicant: Pari Respiratory Equipment, Inc..

Clearance details

Applicant: Pari Respiratory Equipment, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2010-02-16
Decision date: 2010-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian, VA, US

Download summary PDF View on FDA.gov ↗

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.