BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003— 510(k) K061099

Substantially Equivalent

Hoffman Laboratories, LLC

FDA 510(k) clearance K061099 for BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003, Substantially Equivalent on 2006-08-11. Applicant: Hoffman Laboratories, LLC.

Clearance details

Applicant: Hoffman Laboratories, LLC
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2006-04-19
Decision date: 2006-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.