IQ NASAL MASK, MODEL 50160 REV. D— 510(k) K021534

Substantially Equivalent

Sleepnet Corporation

FDA 510(k) clearance K021534 for IQ NASAL MASK, MODEL 50160 REV. D, Substantially Equivalent on 2002-07-02. Applicant: Sleepnet Corporation.

Clearance details

Applicant: Sleepnet Corporation
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2002-05-10
Decision date: 2002-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Manchester, NH, 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.